Prosthetic valve with pivoting tissue anchor portions

ABSTRACT

Prosthetic heart valves and methods of use of prosthetic heart valves may be provided. In one implementation, a prosthetic heart valve may include an annular valve body and atrial anchors and ventricular anchors extending from the valve body. An atrial anchor may include a pivoting portion configured to extend in an upstream direction when the prosthetic heart valve is in a delivery configuration and in a downstream direction when the prosthetic heart valve is in a deployed-anchor configuration. A portion of a ventricular anchor may be configured to abut the annular valve body when the prosthetic heart valve is arranged in the delivery configuration.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/682,789, filed Aug. 22, 2017, now pending, which is a continuation ofU.S. patent application Ser. No. 15/541,783, filed Jul. 6, 2017, whichissued as U.S. Pat. No. 9,974,651 on May 22, 2018, which is a U.S.national stage entry under 35 U.S.C. § 371 of International ApplicationNo. PCT/IL2016/050125, filed Feb. 3, 2016, which claims priority fromU.S. Provisional Patent Application No. 62/112,343, filed Feb. 5, 2015,all of which are hereby incorporated by reference in their entirety.This application also claims priority from U.S. Provisional PatentApplication No. 62/560,384, filed Sep. 19, 2017, which is herebyincorporated by reference in its entirety.

FIELD OF THE INVENTION

Some embodiments of the present invention relate in general to valvereplacement. More specifically, some embodiments of the presentinvention relate to prosthetic valves for replacement of a cardiacvalve.

BACKGROUND

Ischemic heart disease causes regurgitation of a heart valve by thecombination of ischemic dysfunction of the papillary muscles, and thedilatation of the ventricle that is present in ischemic heart disease,with the subsequent displacement of the papillary muscles and thedilatation of the valve annulus.

Dilatation of the annulus of the valve prevents the valve leaflets fromfully coapting when the valve is closed. Regurgitation of blood from theventricle into the atrium results in increased total stroke volume anddecreased cardiac output, and ultimate weakening of the ventriclesecondary to a volume overload and a pressure overload of the atrium.

SUMMARY OF THE INVENTION

For some embodiments of the present invention, an implant is providedhaving a tubular portion, an upstream support portion and one or moreflanges. The implant is percutaneously deliverable to a native heartvalve in a compressed state, and is expandable at the native valve. Theimplant and its delivery system facilitate causing the upstream supportportion and the flanges to protrude radially outward from the tubularportion without expanding the tubular portion. Expansion of the tubularportion brings the upstream support portion and the flanges closertogether, for securing the implant at the native valve by sandwichingtissue of the native valve between the upstream support portion and theflanges.

In accordance with an embodiment of the present invention, an apparatusis provided for use with a native valve that is disposed between anatrium and a ventricle of a heart of a subject, the apparatus including:a valve frame, including a tubular portion that circumscribes alongitudinal axis of the valve frame so as to define a lumen along theaxis, the tubular portion defining a plurality of valve-frame couplingelements disposed circumferentially around the longitudinal axis; aplurality of prosthetic leaflets, coupled to the frame, disposed withinthe lumen, and arranged to provide unidirectional flow of blood from anupstream end of the lumen to a downstream end of the lumen; an outerframe: including a ring defined by a pattern of alternating peaks andtroughs, the peaks being longitudinally closer to the upstream end thanto the downstream end, and the troughs being longitudinally closer tothe downstream end than to the upstream end, and the pattern of the ringhaving an amplitude longitudinally between the peaks and the troughs,including a plurality of legs, each of the legs coupled to the ring at arespective trough, and shaped to define a plurality of outer-framecoupling elements, each of the outer-frame coupling elements (i) coupledto the ring at a respective peak, and (ii) fixed with respect to arespective valve-frame coupling element, and: the tubular portion has(i) a compressed state in which the tubular portion has a compresseddiameter, and (ii) an expanded state in which the tubular portion has anexpanded diameter that is greater than the compressed diameter, and thefixation of the outer-frame coupling elements to the valve-framecoupling elements is such that compression of the tubular portion fromthe expanded state toward the compressed state such that the valve-framecoupling elements pull the outer-frame coupling elements radiallyinward: (i) reduces a circumferential distance between each of theouter-frame coupling elements and its adjacent outer-frame couplingelements, and (ii) increases the amplitude of the pattern of the ring.

In an embodiment, the ring circumscribes the tubular portion.

In an embodiment, the valve-frame coupling elements are disposedcircumferentially around the longitudinal axis between the upstream endand the downstream end but not at the upstream end nor at the downstreamend.

In an embodiment, the upstream support portion includes one or morefabric pockets disposed circumferentially, each pocket of the one ormore pockets having an opening that faces a downstream direction.

In an embodiment, the outer frame is coupled to the valve frame only viathe fixation of the outer-frame coupling elements to the respectivevalve-frame coupling elements.

In an embodiment, the apparatus further includes an upstream supportportion that includes a plurality of arms that extend radially from thetubular portion, and the upstream support portion has (i) aconstrained-arm state, and (ii) a released-arm state in which the armsextend radially outward from the tubular portion, each leg has atissue-engaging flange that has (i) a constrained-flange state, and (ii)a released-flange state in which the flange extends radially outwardfrom the tubular portion, and the apparatus has an intermediate state inwhich (i) the tubular portion is in its compressed state, (ii) theupstream support portion is in its released-arm state, and (iii) thelegs are in their released-flange state.

In an embodiment, the apparatus includes an implant that includes thevalve frame, the leaflets, and the outer frame, and the apparatusfurther includes a tool: including a delivery capsule dimensioned (i) tohouse and retain the implant in a compressed state of the implant inwhich (a) the tubular portion is in its compressed state, (b) theupstream support portion is in its constrained-arm state, and (c) thelegs are in their constrained-flange state, and (ii) to be advancedpercutaneously to the heart of the subject while the implant is housedand in its compressed state, and operable from outside the subject to:transition the implant from its compressed state into the intermediatestate while retaining the tubular portion in its compressed state, andsubsequently, expand the tubular portion toward its expanded state.

In an embodiment, the tool is operable from outside the subject totransition the implant from its compressed state into the intermediatestate by (i) releasing the legs into their released-flange state, whileretaining the tubular portion in its compressed state, and (ii)subsequently, releasing the upstream support portion into itsreleased-arm state, while retaining the tubular portion in itscompressed state.

In an embodiment, the tool is operable from outside the subject totransition the implant from its compressed state into the intermediatestate by (i) releasing the upstream support portion into itsreleased-arm state, while retaining the tubular portion in itscompressed state, and (ii) subsequently, releasing the legs into theirreleased-flange state, while retaining the tubular portion in itscompressed state.

In an embodiment, the fixation of the outer-frame coupling elements tothe valve-frame coupling elements is such that, when the apparatus is inits intermediate state, expansion of the tubular portion from itscompressed state toward its expanded state moves the flangeslongitudinally away from the valve-frame coupling elements.

In an embodiment, the fixation of the outer-frame coupling elements tothe valve-frame coupling elements is such that, when the apparatus is inits intermediate state, expansion of the tubular portion from acompressed state toward an expanded state reduces the amplitude of thepattern of the ring and passes the flanges between the arms.

In an embodiment, the upstream support portion further includes acovering that covers the arms to form an annular shape in thereleased-arm state, and, when the apparatus is in its intermediatestate, expansion of the tubular portion from its compressed state towardits expanded state presses the flanges onto the covering.

In an embodiment, in the compressed state of the tubular portion, adownstream end of each leg of the tubular portion is longitudinallycloser than the valve-frame coupling elements to the downstream end, andthe flange of each leg is disposed longitudinally closer than thevalve-frame coupling elements to the upstream end.

In an embodiment, in the expanded state of the tubular portion, thedownstream end of each leg is longitudinally closer than the valve-framecoupling elements to the downstream end, and the flange of each leg isdisposed longitudinally closer than the valve-frame coupling elements tothe upstream end.

In accordance with an embodiment of the present invention, an apparatusfor use with a native valve of a heart of a subject is provided, theapparatus having an implant that includes: a valve frame that includes atubular portion that circumscribes a longitudinal axis of the valveframe so as to define a lumen along the axis, the tubular portion havingan upstream end, a downstream end, a longitudinal length therebetween,and a diameter transverse to the longitudinal axis; a valve member,coupled to the tubular portion, disposed within the lumen, and arrangedto provide unidirectional upstream-to-downstream flow of blood throughthe lumen; an upstream support portion, coupled to the tubular portion;and an outer frame, coupled to the tubular portion, and including atissue-engaging flange, and: the implant has a first state and a secondstate, in both the first state and the second state, (i) the upstreamsupport portion extends radially outward from the tubular portion, and(ii) the tissue-engaging flange extends radially outward from thetubular portion, and the tubular portion, the upstream support portion,and the outer frame are arranged such that transitioning of the implantfrom the first state toward the second state: increases the diameter ofthe tubular portion by a diameter-increase amount, decreases the lengthof the tubular portion by a length-decrease amount, and moves the flangea longitudinal distance toward or toward-and-beyond the upstream supportportion, the distance being greater than the length-decrease amount.

In an embodiment of the present invention, the tubular portion, theupstream support portion, and the outer frame may be arranged such thatthe longitudinal distance is more than 20 percent greater than thelength-decrease amount.

In an embodiment, the tubular portion, the upstream support portion, andthe outer frame may be arranged such that the longitudinal distance ismore than 30 percent greater than the length-decrease amount.

In an embodiment, the tubular portion, the upstream support portion, andthe outer frame may be arranged such that the longitudinal distance ismore than 40 percent greater than the length-decrease amount.

In accordance with an embodiment of the present invention, an apparatusfor use with a native valve that is disposed between an atrium and aventricle of a heart of a subject is provided, the apparatus including:a valve frame, including a tubular portion that circumscribes alongitudinal axis of the valve frame so as to define a lumen along theaxis; a plurality of prosthetic leaflets, coupled to the frame, disposedwithin the lumen, and arranged to provide unidirectional flow of bloodfrom an upstream end of the lumen to a downstream end of the lumen; anouter frame, including: a ring defined by a pattern of alternating peaksand troughs: the peaks being longitudinally closer than the troughs tothe upstream end, the peaks being fixed to respective sites of thetubular portion at respective coupling points disposed circumferentiallyaround the longitudinal axis, and the pattern of the ring having anamplitude longitudinally between the peaks and the troughs; and aplurality of legs, each of the legs coupled to the ring at a respectivetrough, and: the tubular portion has (i) a compressed state in which thetubular portion has a compressed diameter, and (ii) an expanded state inwhich the tubular portion has an expanded diameter that is greater thanthe compressed diameter, and the fixation of the peaks to the respectivesites of the tubular portion is such that compression of the tubularportion from the expanded state toward the compressed state such thatthe respective sites of the tubular portion pull the peaks radiallyinward via radially-inward tension on the coupling points: (i) reduces acircumferential distance between each of the coupling points and itsadjacent coupling points, and (ii) increases the amplitude of thepattern of the ring.

In an embodiment, the outer frame may be coupled to the valve frame onlyvia the fixation of the peaks to the respective sites of the tubularportion at the respective coupling points.

In accordance with an embodiment of the present invention, an apparatusfor use with a native valve that is disposed between an atrium and aventricle of a heart of a subject is provided, the apparatus including:a valve frame, including a tubular portion that circumscribes alongitudinal axis of the valve frame so as to define a lumen along theaxis, the valve frame defining a plurality of valve-frame couplingelements disposed circumferentially around the longitudinal axis; aplurality of prosthetic leaflets, coupled to the frame, disposed withinthe lumen, and arranged to provide unidirectional flow of blood from anupstream end of the lumen to a downstream end of the lumen; an outerframe: including a ring defined by a pattern of alternating peaks andtroughs, the peaks being longitudinally closer to the upstream end thanto the downstream end, and the troughs being longitudinally closer tothe downstream end than to the upstream end, and the pattern of the ringhaving an amplitude longitudinally between the peaks and the troughs,including a plurality of legs, each of the legs coupled to the ring at arespective trough, and shaped to define a plurality of outer-framecoupling elements, each of the outer-frame coupling elements (i) coupledto the ring at a respective peak, and (ii) fixed with respect to arespective valve-frame coupling element, and: the tubular portion has(i) a compressed state in which the tubular portion has a compresseddiameter, and (ii) an expanded state in which the tubular portion has anexpanded diameter that is greater than the compressed diameter, and thefixation of the outer-frame coupling elements with respect to thevalve-frame coupling elements is such that compression of the tubularportion from the expanded state toward the compressed state (i) pullsthe outer-frame coupling elements radially inward via radially-inwardpulling of the valve-frame coupling elements on the outer-frame couplingelements, (ii) reduces a circumferential distance between each of theouter-frame coupling elements and its adjacent outer-frame couplingelements, and (iii) increases the amplitude of the pattern of the ring,without increasing a radial gap between the valve frame and the ring bymore than 1.5 mm.

In an embodiment, the outer frame may be coupled to the valve frame onlyvia the fixation of the outer-frame coupling elements to the respectivevalve-frame coupling elements.

There is further provided, in accordance with an embodiment of thepresent invention, an apparatus for use with a native valve that isdisposed between an atrium and a ventricle of a heart of a subject isprovided, the apparatus including: a valve frame, including a tubularportion that circumscribes a longitudinal axis of the valve frame so asto define a lumen along the axis; a plurality of prosthetic leaflets,coupled to the frame, disposed within the lumen, and arranged to provideunidirectional flow of blood from an upstream end of the lumen to adownstream end of the lumen; an outer frame, including: a ring definedby a pattern of alternating peaks and troughs: the peaks beinglongitudinally closer than the troughs to the upstream end, the peaksbeing fixed to respective sites of the tubular portion at respectivecoupling points disposed circumferentially around the longitudinal axis,and the pattern of the ring having an amplitude longitudinally betweenthe peaks and the troughs; and a plurality of legs, each of the legscoupled to the ring at a respective trough, and: the tubular portion has(i) a compressed state in which the tubular portion has a compresseddiameter, and (ii) an expanded state in which the tubular portion has anexpanded diameter that is greater than the compressed diameter, and thefixation of the peaks to the respective sites of the tubular portion issuch that compression of the tubular portion from the expanded statetoward the compressed state (i) pulls the peaks radially inward viaradially-inward pulling of the respective sites of the tubular portionon the peaks, (ii) reduces a circumferential distance between each ofthe coupling points and its adjacent coupling points, and (iii)increases the amplitude of the pattern of the ring, without increasing aradial gap between the valve frame and the ring by more than 1.5 mm.

In an embodiment, the outer frame may be coupled to the valve frame onlyvia the fixation of the peaks to the respective sites of the tubularportion at the respective coupling points.

In accordance with an embodiment of the present invention, an apparatusfor use with a native valve disposed between an atrium and a ventricleof a heart of a subject is provided, the apparatus including: a valveframe, including a tubular portion that circumscribes a longitudinalaxis of the valve frame so as to define a lumen along the axis, thetubular portion having an upstream end, a downstream end, and defining aplurality of valve-frame coupling elements disposed circumferentiallyaround the longitudinal axis between the upstream end and the downstreamend but not at the upstream end nor at the downstream end; a pluralityof prosthetic leaflets, disposed within the lumen, and arranged toprovide unidirectional flow of blood through the lumen; an outer frame:including a ring defined by a pattern of alternating peaks and troughs,the peaks being longitudinally closer to the upstream end than to thedownstream end, and the troughs being longitudinally closer to thedownstream end than to the upstream end, including a plurality of legs,each of the legs coupled to the ring at a respective trough, and shapedto define a plurality of outer-frame coupling elements, each of theouter-frame coupling elements (i) coupled to the ring at a respectivepeak, and (ii) fixed with respect to a respective valve-frame couplingelement at a respective coupling point, and: the tubular portion has (i)a compressed state in which the tubular portion has a compresseddiameter, and (ii) an expanded state in which the tubular portion has anexpanded diameter that is greater than the compressed diameter, andexpansion of the tubular portion from the compressed state toward theexpanded state (i) increases a circumferential distance between each ofthe outer-frame coupling elements and its adjacent outer-frame couplingelements, and (ii) moves the plurality of legs in a longitudinallyupstream direction with respect to the tubular portion.

In an embodiment, the outer frame may be coupled to the valve frame onlyvia the fixation of the outer-frame coupling elements to the respectivevalve-frame coupling elements.

In accordance with an embodiment of the present invention, an apparatusfor use with a native valve disposed between an atrium and a ventricleof a heart of a subject is provided, the apparatus including: a valveframe, including a tubular portion that circumscribes a longitudinalaxis of the valve frame so as to define a lumen along the axis, thetubular portion having an upstream end and a downstream end; a pluralityof prosthetic leaflets, disposed within the lumen, and arranged toprovide unidirectional flow of blood through the lumen; an outer frame,including: a ring defined by a pattern of alternating peaks and troughs:the peaks being longitudinally closer than the troughs to the upstreamend, the peaks being fixed to respective sites of the tubular portion atrespective coupling points disposed circumferentially around thelongitudinal axis between the upstream end and the downstream end butnot at the upstream end nor the downstream end; and a plurality of legs,each of the legs coupled to the ring at a respective trough, and: thetubular portion has (i) a compressed state in which the tubular portionhas a compressed diameter, and (ii) an expanded state in which thetubular portion has an expanded diameter that is greater than thecompressed diameter, and expansion of the tubular portion from thecompressed state toward the expanded state (i) increases acircumferential distance between each of the coupling points and itsadjacent coupling points, and (ii) moves the plurality of legs in alongitudinally upstream direction with respect to the tubular portion.

In an embodiment, the outer frame may be coupled to the valve frame onlyvia the fixation of the peaks to the respective sites of the tubularportion at the respective coupling points.

In accordance with an embodiment of the present invention, an apparatusfor use with a native valve of a heart of a subject is provided, theapparatus including: a frame assembly, having an upstream end and adownstream end, and a central longitudinal axis therebetween, andincluding: a valve frame, including: a tubular portion having anupstream end and a downstream end, and shaped to define a lumentherebetween, and an upstream support portion, extending from theupstream end of the tubular portion; and at least one leg, coupled tothe valve frame at a coupling point, and having a tissue-engagingflange; and a valve member disposed within the lumen, and configured tofacilitate one-way liquid flow through the lumen from the upstream endof the tubular portion to the downstream end of the tubular portion, andthe frame assembly: has a compressed state, for percutaneous delivery tothe heart, in which the tubular portion has a compressed diameter, isbiased to assume an expanded state in which the tubular portion has anexpanded diameter that is greater than the compressed diameter, and isconfigured such that increasing the diameter of the tubular portiontoward the expanded diameter causes longitudinal movement: of theupstream support portion toward the coupling point, and of thetissue-engaging flange away from the coupling point.

In an embodiment: the apparatus includes an implant that includes theframe assembly and the valve member, and the apparatus further includesa tool: including a delivery capsule dimensioned (i) to house and retainthe implant in the compressed state, and (ii) to be advancedpercutaneously to the heart of the subject while the implant is housedand in the compressed state, and operable from outside the subject tofacilitate an increase of the diameter of the tubular portion from thecompressed diameter toward the expanded diameter such that the increaseof the diameter actuates longitudinal movement: of the upstream supportportion toward the coupling point, and of the tissue-engaging flangeaway from the coupling point.

In an embodiment, the frame assembly may be configured such thatincreasing the diameter of the tubular portion by expanding the frameassembly toward the expanded state causes longitudinal movement of theupstream end of the tubular portion toward the coupling point.

In an embodiment, the coupling point is disposed closer to thedownstream end of the frame assembly than are either the tissue-engagingflange or the upstream support portion.

In an embodiment, in the expanded state of the frame assembly, the legextends away from the central longitudinal axis.

In an embodiment, the expanded state of the frame assembly may be afully-expanded state of the frame assembly, the leg is expandable intoan expanded state of the leg, independently of increasing the diameterof the tubular portion, and in the expanded state of the leg, the legextends away from the central longitudinal axis.

In an embodiment, in the expanded state of the frame assembly, the legextends away from the central longitudinal axis, and in the compressedstate of the frame assembly, the leg is generally parallel with thecentral longitudinal axis.

In an embodiment, the frame assembly may be configured such that thelongitudinal movement of the tissue-engaging flange away from thecoupling point is a translational movement of the tissue-engaging flangethat does not include rotation of the tissue-engaging flange.

In an embodiment, the frame assembly may be configured such thatincreasing the diameter of the tubular portion by expanding the frameassembly toward the expanded state causes 1-20 mm of longitudinalmovement of the tissue-engaging flange away from the coupling point.

In an embodiment, the frame assembly may be configured such thatincreasing the diameter of the tubular portion by expanding the frameassembly toward the expanded state causes 1-20 mm of longitudinalmovement of the upstream support portion toward the coupling point.

In an embodiment, the frame assembly may be configured such thatincreasing the diameter of the tubular portion by expanding the frameassembly toward the expanded state reduces a distance between theupstream support portion and the tissue-engaging flange by 5-30 mm.

In an embodiment, the frame assembly may be configured such thatincreasing the diameter of the tubular portion by expanding the frameassembly toward the expanded state moves the tissue-engaging flangelongitudinally past the upstream support portion.

In an embodiment, the tubular portion may be defined by a plurality ofcells of the valve frame, and increasing the diameter of the tubularportion by expanding the frame assembly toward the expanded state:includes (i) increasing a width, orthogonal to the longitudinal axis ofthe frame assembly, of each cell, and (ii) reducing a height, parallelwith the longitudinal axis of the frame assembly, of each cell, andcauses longitudinal movement of the upstream support portion toward thecoupling point by reducing a height, parallel with the longitudinal axisof the frame assembly, of the tubular portion, by reducing the height ofeach cell.

In an embodiment, the leg is disposed on an outside of the tubularportion.

In an embodiment, the at least one leg includes a plurality of legs, thecoupling point includes a plurality of coupling points, and the frameassembly includes a leg frame that circumscribes the tubular portion,includes the plurality of legs, and is coupled to the valve frame at theplurality of coupling points, such that the plurality of legs isdistributed circumferentially around the tubular portion.

In an embodiment, the plurality of coupling points is disposedcircumferentially around the frame assembly on a transverse plane thatis orthogonal to the longitudinal axis of the frame assembly.

In an embodiment, the plurality of legs may be coupled to the valveframe via a plurality of struts, each strut having a first end that iscoupled to a leg of the plurality of legs, and a second end that iscoupled to a coupling point of the plurality of coupling points, in thecompressed state of the frame assembly, being disposed at a first anglein which the first end is disposed closer to the downstream end of theframe assembly than is the second end, and being deflectable withrespect to the coupling point of the plurality of coupling points, suchthat increasing the diameter of the tubular portion by expanding theframe assembly toward the expanded state causes the strut to deflect toa second angle in which the first end is disposed further from thedownstream end of the frame assembly than is the first end in thecompressed state of the frame assembly.

In an embodiment, the leg frame may be structured such that each leg ofthe plurality of legs is coupled to two struts of the plurality ofstruts, and two struts of the plurality of struts are coupled to eachcoupling point of the plurality of coupling points.

In an embodiment, the leg may be coupled to the valve frame via a strut,the strut having a first end that is coupled to the leg, and a secondend that is coupled to the coupling point, in the compressed state ofthe frame assembly, being disposed at a first angle in which the firstend is disposed closer to the downstream end of the frame assembly thanis the second end, and being deflectable with respect to the couplingpoint, such that increasing the diameter of the tubular portion byexpanding the frame assembly toward the expanded state causes the strutto deflect to a second angle in which the first end is disposed furtherfrom the downstream end of the frame assembly than is the first end inthe compressed state of the frame assembly.

In an embodiment, the at least one leg includes at least a first leg anda second leg.

In an embodiment, the first leg and the second leg are both coupled tothe valve frame at the coupling point.

In an embodiment, the first leg may be coupled to the coupling point viaa respective first strut, and the second leg is coupled to the couplingpoint via a respective second strut.

In an embodiment, the first and second legs, the first and secondstruts, and the coupling point are arranged such that, in the expandedstate of the frame assembly: the coupling point is disposed,circumferentially with respect to the tubular portion, between the firststrut and the second strut, the first strut is disposed,circumferentially with respect to the tubular portion, between thecoupling point and the first leg, and the second strut is disposed,circumferentially with respect to the tubular portion, between thecoupling point and the second leg.

In an embodiment, the coupling point includes at least a first couplingpoint and a second coupling point.

In an embodiment, the leg is coupled to the valve frame at the firstcoupling point and at the second coupling point.

In an embodiment, the leg may be coupled to the first coupling point viaa respective first strut, and to the second coupling point via arespective second strut.

In an embodiment, the first and second legs, the first and secondstruts, and the coupling point are arranged such that, in the expandedstate of the frame assembly: the leg is disposed, circumferentially withrespect to the tubular portion, between the first strut and the secondstrut, the first strut is disposed, circumferentially with respect tothe tubular portion, between the leg and the first coupling point, andthe second strut is disposed, circumferentially with respect to thetubular portion, between the leg and the second coupling point.

In an embodiment, in the expanded state of the frame assembly, theupstream support portion extends radially outward from the tubularportion.

In an embodiment, the expanded state of the frame assembly is afully-expanded state of the frame assembly, the upstream support portionis expandable into an expanded state of the upstream support portion,independently of increasing the diameter of the tubular portion, and inthe expanded state of the upstream support portion, the upstream supportportion extends radially outward from the tubular portion.

In an embodiment, in the compressed state of the frame assembly, theupstream support portion is generally tubular, collinear with thetubular portion, and disposed around the central longitudinal axis.

In an embodiment, in the expanded state of the frame assembly, an innerregion of the upstream support portion extends radially outward from thetubular portion at a first angle with respect to the tubular portion,and an outer region of the upstream support portion extends, from theinner region of the upstream support portion, further radially outwardfrom the tubular portion at a second angle with respect to the tubularportion, the second angle being smaller than the first angle.

In accordance with an embodiment of the present invention, an apparatusfor use with a native valve of a heart of a subject is provided, theapparatus including a frame assembly, having an upstream end and adownstream end, and a central longitudinal axis therebetween, andincluding: a valve frame, including: a tubular portion having anupstream end and a downstream end, and shaped to define a lumentherebetween, and an upstream support portion, extending from theupstream end of the tubular portion; and at least one leg, coupled tothe valve frame at a coupling point, and having a tissue-engagingflange; and a valve member disposed within the lumen, and configured tofacilitate one-way liquid flow through the lumen from the upstream endof the tubular portion to the downstream end of the tubular portion, andthe frame assembly: has a compressed state, for percutaneous delivery tothe heart, in which the tubular portion has a compressed diameter, isbiased to assume an expanded state in which the tubular portion has anexpanded diameter that is greater than the compressed diameter, and isconfigured such that reducing the diameter of the tubular portion towardthe compressed diameter causes longitudinal movement of the upstreamsupport portion away from the coupling point, and of the tissue-engagingflange toward the coupling point.

In accordance with an embodiment of the present invention, an apparatusfor use with a native valve of a heart of a subject is provided, theapparatus including a frame assembly, having an upstream end and adownstream end, and a central longitudinal axis therebetween, including:a valve frame, including: a tubular portion having an upstream end and adownstream end, and shaped to define a lumen therebetween, and anupstream support portion, extending from the upstream end of the tubularportion; and at least one leg, coupled to the valve frame at a couplingpoint, and having a tissue-engaging flange; and a valve member disposedwithin the lumen, and configured to facilitate one-way liquid flowthrough the lumen from the upstream end of the tubular portion to thedownstream end of the tubular portion, and the frame assembly: has acompressed state, for percutaneous delivery to the heart, isintracorporeally expandable into an expanded state in which a diameterof the tubular portion is greater than in the compressed state, and isconfigured such that increasing the diameter of the tubular portion byexpanding the frame assembly toward the expanded state causeslongitudinal movement of the tissue-engaging flange away from thecoupling point.

In accordance with an embodiment of the present invention, an apparatusfor use with a native valve of a heart of a subject is provided, theapparatus including a frame assembly, having an upstream end and adownstream end, and a central longitudinal axis therebetween, andincluding: an inner frame including an inner-frame tubular portion thatcircumscribes the central longitudinal axis, has an upstream end and adownstream end, and defines a channel therebetween, the inner framedefining a plurality of inner-frame couplings disposed circumferentiallyat a longitudinal location of the inner frame, an outer frame includingan outer-frame tubular portion that coaxially circumscribes at least aportion of the inner-frame tubular portion, the outer frame defining aplurality of outer-frame couplings disposed circumferentially at alongitudinal location of the outer frame, and a plurality of connectors,each connector connecting a respective inner-frame coupling to arespective outer-frame coupling; a liner, disposed over at least part ofthe inner-frame tubular portion; and a plurality of prosthetic leaflets,coupled to the inner-frame tubular portion and disposed within thechannel, and: the frame assembly: (i) is compressible by aradially-compressive force into a compressed state in which the innerframe is in a compressed state thereof and the outer frame is in acompressed state thereof, (ii) is configured, upon removal of theradially-compressive force, to automatically expand into an expandedstate thereof in which the inner frame is in an expanded state thereofand the outer frame is in an expanded state thereof, in the expandedstate of the frame assembly, the prosthetic leaflets are configured tofacilitate one-way fluid flow, in a downstream direction, through thechannel, and the connection of the inner-frame couplings to therespective outer-frame couplings is such that expansion of the frameassembly from the compressed state to the expanded state causes theinner-frame tubular portion to slide longitudinally in a downstreamdirection with respect to the outer-frame tubular portion.

In accordance with an embodiment of the present invention, an apparatusfor use with a native valve disposed between an atrium and a ventricleof a heart of a subject is provided, the apparatus including: a tubularportion, having an upstream portion that includes an upstream end, and adownstream portion that includes a downstream end, and shaped to definea lumen between the upstream portion and the downstream portion; aplurality of prosthetic leaflets, disposed within the lumen, andarranged to provide unidirectional flow of blood from the upstreamportion to the downstream portion; an annular upstream support portion:having an inner portion that extends radially outward from the upstreamportion, and including one or more fabric pockets disposedcircumferentially around the inner portion, each pocket of the one ormore pockets having an opening that faces a downstream direction.

In an embodiment, the upstream support portion includes (i) a pluralityof arms that extend radially outward from the tubular portion, and (ii)a covering, disposed over the plurality of arms, each arm has (i) aradially-inner part at the inner portion of the upstream supportportion, and (ii) a radially-outer part at the outer portion of theupstream support portion, at the inner portion of the upstream supportportion, the covering is closely-fitted between the radially-inner partsof the arms, and at the outer portion of the upstream support portion,the pockets are formed by the covering being loosely-fitted between theradially-outer parts of the arms.

In an embodiment, the upstream support portion includes (i) a pluralityof arms that extend radially outward from the tubular portion, and (ii)a covering, disposed over the plurality of arms, each arm has (i) aradially-inner part at the inner portion of the upstream supportportion, and (ii) a radially-outer part at the outer portion of theupstream support portion, the radially-outer part being more flexiblethan the radially-inner part.

In an embodiment, the upstream support portion includes (i) a pluralityof arms that extend radially outward from the tubular portion, and (ii)a covering, disposed over the plurality of arms, each arm has (i) aradially-inner part at the inner portion of the upstream supportportion, and (ii) a radially-outer part at the outer portion of theupstream support portion, at the outer portion of the upstream supportportion, the pockets are formed by each arm curving to form a hookshape.

In an embodiment, each pocket may be shaped and arranged to billow inresponse to perivalvular flow of blood in an upstream direction.

In an embodiment, the apparatus may be configured to be transluminallydelivered to the heart and implanted at the native valve by expansion ofthe apparatus, such that the upstream support portion is disposed in theatrium and the tubular portion extends from the upstream support portioninto the ventricle, and each pocket is shaped and arranged such thatperivalvular flow of blood in an upstream direction presses the pocketagainst tissue of the atrium.

In accordance with an embodiment of the present invention, an apparatusis provided including a plurality of prosthetic valve leaflets; and aframe assembly, including: a tubular portion defined by a repeatingpattern of cells, the tubular portion extending circumferentially arounda longitudinal axis so as to define a longitudinal lumen, the prostheticvalve leaflets coupled to the inner frame and disposed within the lumen;an outer frame, including a plurality of legs, distributedcircumferentially around the tubular portion, each leg having atissue-engaging flange; an upstream support portion that includes aplurality of arms that extend radially outward from the tubular portion;and a plurality of appendages, each having a first end that defines acoupling element via which the tubular portion is coupled to the outerframe, and a second end; and the frame assembly defines a plurality ofhubs, distributed circumferentially around the longitudinal axis on aplane that is transverse to the longitudinal axis, each hub defined byconvergence and connection of, (i) two adjacent cells of the tubularportion, (ii) an arm of the plurality of arms, and (iii) an appendage ofthe plurality of appendages.

In an embodiment, each hub has six radiating spokes, two of the sixspokes being part of a first cell of the two adjacent cells, two of thesix spokes being part of a second cell of the two adjacent cells, one ofthe six spokes being the arm, and one of the six spokes being the secondend of the appendage.

In an embodiment, the appendages are in-plane with the tubular portion.

In an embodiment, the appendages are in-plane with the outer frame.

In accordance with an embodiment of the present invention, a method foruse with a native valve of a heart of a subject is provided, the methodincluding percutaneously advancing to heart, an implant: including avalve frame, a valve member disposed within a lumen defined by the valveframe, and at least one leg, coupled to the valve frame at a couplingpoint, and having an upstream end, a downstream end, and a centrallongitudinal axis therebetween; positioning the implant within the heartsuch that a tissue-engaging flange of the leg is disposed downstream ofthe valve, and thereafter causing the flange to protrude radiallyoutward from the axis; subsequently, while an upstream support portionof the valve frame is disposed upstream of the valve, causing theupstream support portion to protrude radially outward from the axis,such that tissue of the valve is disposed between the upstream supportportion and the flange; and subsequently, sandwiching the tissue betweenthe upstream support portion and the flange by reducing a distancebetween the upstream support portion and the flange by causinglongitudinal movement (i) of the upstream support portion toward thecoupling point, and (ii) of the tissue-engaging flange away from thecoupling point.

In an embodiment, causing the longitudinal movement (i) of the upstreamsupport portion toward the coupling point, and (ii) of thetissue-engaging flange away from the coupling point, includes causingthe longitudinal movement by increasing a diameter of the lumen.

In accordance with an embodiment of the present invention, a method foruse with a native valve of a heart of a subject is provided, the methodincluding percutaneously advancing to heart, an implant: including avalve frame, a valve member disposed within a lumen defined by the valveframe, and at least one leg, coupled to the valve frame at a couplingpoint, and having an upstream end, a downstream end, and a centrallongitudinal axis therebetween; positioning the implant within the heartsuch that an upstream support portion of the valve frame is disposedupstream of the valve, and thereafter causing the upstream supportportion to protrude radially outward from the axis; subsequently, whilea tissue-engaging flange of the leg is disposed downstream of the valve,causing the tissue-engaging flange to protrude radially outward from theaxis, such that tissue of the valve is disposed between the upstreamsupport portion and the flange; and subsequently, sandwiching the tissuebetween the upstream support portion and the flange by reducing adistance between the upstream support portion and the flange by causinglongitudinal movement (i) of the upstream support portion toward thecoupling point, and (ii) of the tissue-engaging flange away from thecoupling point.

In an embodiment, causing the longitudinal movement (i) of the upstreamsupport portion toward the coupling point, and (ii) of thetissue-engaging flange away from the coupling point, includes causingthe longitudinal movement by increasing a diameter of the lumen.

In accordance with an embodiment of the present invention, a method foruse with a native valve of a heart of a subject is provided, the methodincluding: percutaneously advancing an implant to the heart, the implanthaving an upstream end, a downstream end, and a central longitudinalaxis therebetween, and including a tubular portion, an upstream supportportion, and a plurality of tissue-engaging flanges; positioning theimplant within the heart such that the upstream support portion isdisposed upstream of the valve, positioning the implant within the heartsuch that the tissue-engaging flanges are disposed downstream of thevalve, without increasing a diameter of the tubular portion: causing theupstream support portion to extend radially outward from the axis so asto have a first support-portion span, and causing the flanges to extendradially outward from the axis so as to have a first flange span; andsubsequently, causing the upstream support portion and the flanges movetoward each other by at least 5 mm by increasing a diameter of thetubular portion such that: the upstream support portion extends radiallyoutward so as to have a second support-portion span, the firstsupport-portion span being at least 40 percent as great as the secondsupport-portion span, and the flanges extend radially outward so as tohave a second flange span, the first flange span being at least 30percent as great as the second flange span.

There is further provided, in accordance with an application of thepresent invention, a method for use with a native valve of a heart of asubject, the method including: percutaneously advancing an implant tothe heart, the implant: having an upstream end, a downstream end, and acentral longitudinal axis therebetween, and including a tubular portion,an upstream support portion, and a plurality of tissue-engaging flanges;positioning the implant within the heart such that the upstream supportportion is disposed upstream of the valve, positioning the implantwithin the heart such that the tissue-engaging flanges are disposeddownstream of the valve, without increasing a diameter of the tubularportion: causing the upstream support portion to extend radially outwardfrom the axis, and causing the flanges to extend radially outward fromthe axis so as to have a first flange span; and subsequently, byincreasing a diameter of the tubular portion: causing the upstreamsupport portion and the flanges move toward each other by at least 5 mm,causing the upstream support portion to move further radially outwardfrom the axis, and causing each flange of the plurality of flanges totranslate radially outward so as to have a second flange span that isgreater than the first flange span.

The present invention will be more fully understood from the followingdetailed description of applications thereof, taken together with thedrawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-B and 2A-E are schematic illustrations of an implant for usewith a native valve of a heart of a subject, in accordance with someapplications of the invention;

FIGS. 3A-C are schematic illustrations that show structural changes in aframe assembly during transitioning of the assembly between itscompressed and expanded states, in accordance with some applications ofthe invention;

FIGS. 4A-F are schematic illustrations of implantation of the implant atthe native valve, in accordance with some applications of the invention;

FIG. 5 is a schematic illustration of a step in the implantation of theimplant, in accordance with some applications of the invention;

FIG. 6 is a schematic illustration of the implant, in accordance withsome applications of the invention;

FIGS. 7A-B and 8A-B are schematic illustrations of frame assemblies ofrespective implants, in accordance with some applications of theinvention; and

FIGS. 9A-C are schematic illustrations of an implant comprising a frameassembly, in accordance with some applications of the invention.

DETAILED DESCRIPTION OF EMBODIMENTS

Reference is made to FIGS. 1A-B and 2A-E, which are schematicillustrations of an implant 20 for use with a native valve of a heart ofa subject, in accordance with some embodiments of the invention. Implant20 comprises a frame assembly 22 (alternatively, “annular valve body22”) that has an upstream end 24, a downstream end 26, and a centrallongitudinal axis ax1 therebetween. Annular valve body 22 comprises avalve frame 30 (alternatively “inner frame 30”) that comprises a tubularportion 32 that has an upstream end 34 and a downstream end 36, and isshaped to define a lumen 38 through the tubular portion from theupstream end to the downstream end. Tubular portion 32 circumscribesaxis ax1, and thereby defines lumen 38 along the axis. Inner frame 30further comprises an upstream support portion 40, extending fromupstream end 34 of tubular portion 32. Annular valve body 22 furthercomprises at least one leg 50 (alternatively, “ventricular anchorsupport 50”), coupled to inner frame 30 at (e.g., via) a coupling point52, and having a tissue-engaging flange 54 (alternatively, “ventricularanchoring leg 54”).

In some embodiments, and as described hereinbelow, ventricular anchorsupport 50 is part of an outer frame 60, and frames 30 and 60 definerespective coupling elements 31 and 61, which are fixed with respect toeach other at coupling points 52. As illustrated in FIG. 1A, inner frame30 may be positioned at least partially within outer frame 60. In someembodiments, frames 30 and 60 are coupled to each other only at couplingpoints 52 (e.g., only via the fixation of coupling elements 31 and 61with respect to each other).

Implant 20 further comprises a valve member 58 (e.g., one or moreprosthetic leaflets) disposed within lumen 38, and configured tofacilitate one-way liquid flow through the lumen from upstream end 34 todownstream end 36 (e.g., thereby defining the orientation of theupstream and downstream ends of tubular portion 32). FIG. 1A showsimplant 20 in a fully-expanded state, in which annular valve body 22 isin a fully-expanded state. FIG. 1B shows an exploded view of annularvalve body 22 in its fully-expanded state. FIGS. 2A-E show respectivestates of implant 20, which will be discussed in more detail hereinbelowwith respect to the implantation of the implant and the anatomy in whichthe implant is implanted. FIG. 2A shows implant 20 in a compressed state(in which annular valve body 22 is in a compressed state constituting adelivery configuration), for percutaneous delivery of the implant to theheart of the subject. In some embodiments, in the compressed state,ventricular anchor support 50 (including ventricular anchoring leg 54thereof) is in a constrained-leg state in which the ventricularanchoring leg is generally parallel with axis ax1. Further in someembodiments, in the compressed state, upstream support portion 40 isgenerally tubular, collinear with tubular portion 32 (e.g., extendingcollinearly from the tubular portion), and disposed around axis ax1.

FIG. 2B shows a state of implant 20 in which ventricular anchoring leg54 of each ventricular anchor support 50 extends radially away from axisax1 (e.g., radially away from tubular portion 32). FIG. 2C shows a stateof implant 20 in which upstream-support portion 40 extends radially awayfrom axis ax1 (and thereby radially away from tubular portion 32). Inthe states depicted in FIGS. 2B and 2C, annular valve body 22 isconfigured to remain compressed within the delivery configuration whileventricular anchoring legs 54 and upstream-support portion 40 (includingatrial anchoring arms 46) deflect radially outwards into the deployedconfiguration. FIG. 2D shows a state of implant 20 in which bothventricular anchoring leg 54 and portion 40 extend away from axis ax1.In the fully-expanded state (FIGS. 1A-B) both upstream support portion40 and ventricular anchoring leg 54 extend radially away from axis ax1.In some embodiments, annular valve body 22 is biased (e.g., shape-set)to assume its fully-expanded state, which is shown in FIG. 2E and whichconstitutes a deployed configuration. Transitioning of implant 20between the respective states may be controlled by delivery apparatus,such as by constraining the implant in a compressed state within adelivery tube and/or against a control rod, and selectively releasingportions of the implant to allow them to expand.

In the compressed state of annular valve body 22, tubular portion 32 hasa diameter d1, and in the expanded state, the tubular portion has adiameter d2 that is greater that diameter d1. For some embodiments,diameter d1 is 4-15 mm, (e.g., 5-11 mm) and diameter d2 is 20-50 mm,(e.g., 23-33 mm). Annular valve body 22 is configured such thatincreasing the diameter of tubular portion 32 (e.g., from d1 to d2)causes longitudinal movement of ventricular anchoring leg 54 away fromcoupling point 52. In the same way, reducing the diameter of tubularportion 32 (e.g., from d2 to d1) causes longitudinal movement ofventricular anchoring leg 54 toward coupling point 52. It is to be notedthat the term “longitudinal movement” (including the specification andthe claims) means movement parallel with central longitudinal axis ax1.Therefore longitudinal movement of ventricular anchoring leg 54 awayfrom coupling point 52 means increasing a distance, measured parallelwith longitudinal axis ax1, between ventricular anchoring leg 54 andcoupling point 52. An example of such a configuration is described inmore detail with respect to FIG. 3A.

Thus, expansion of tubular portion 32 from its compressed state towardits expanded state (i) increases a circumferential distance between eachof coupling points 52 and its adjacent coupling points (e.g., betweeneach of outer-frame coupling elements 61 and its adjacent outer-framecoupling elements) (e.g., from d8 to d9), and (ii) moves ventricularanchor support 50 in a longitudinally upstream direction with respect tothe tubular portion. According to some embodiments, such as theembodiments depicted in FIGS. 1B and 3A, because a circumferentialdistance between adjacent coupling points 52 may be equal for allcoupling points 52 (e.g., d8 or d9), a circumferential distance betweenadjacent legs 54 may also be equal for all ventricular anchoring legs54, as each ventricular anchoring leg 54 is disposed between twoadjacent coupling points 52. Thus, ventricular anchoring legs 54 may beconfigured to be spaced at a regular interval about a circumference ofannular valve body 22.

In some embodiments, annular valve body 22 is configured such thatincreasing the diameter of tubular portion 32 also causes longitudinalmovement of upstream support portion 40 toward coupling point 52, e.g.,as described in more detail with respect to FIGS. 3B-C. In someembodiments, annular valve body 22 is configured such that increasingthe diameter of tubular portion 32 also causes longitudinal movement ofupstream end 34 of tubular portion 32 toward coupling point 52. In thesame way, reducing the diameter of tubular portion 32 causeslongitudinal movement of upstream end 34 away from coupling point 52.

For some embodiments, upstream support portion 40 comprises a pluralityof atrial anchoring arms 46 that each extends radially outward fromtubular portion 32 (e.g., from upstream end 34 of the tubular portion).Atrial anchoring arms 46 may be flexible. For some such embodiments,atrial anchoring arms 46 are coupled to tubular portion 32 such thateach arm may deflect independently of adjacent atrial anchoring arms 46during implantation (e.g., due to anatomical topography).

For some embodiments, upstream support portion 40 comprises a pluralityof barbs 48 that extend out of a downstream surface of the upstreamsupport portion. For example, each atrial anchoring arm 46 may compriseone or more of barbs 48. Barbs 48 press into tissue upstream of thenative valve (e.g., into the valve annulus), thereby inhibitingdownstream movement of implant 20 (in addition to inhibition ofdownstream movement provided by the geometry of upstream support portion40).

One or more surfaces of annular valve body 22 are covered with acovering 23, which in some embodiments comprises a flexible sheet, suchas a fabric, e.g., comprising polyester. In some embodiments, covering23 covers at least part of tubular portion 32, in some embodimentslining an inner surface of the tubular portion, and thereby defininglumen 38.

Further in some embodiments, upstream support portion 40 is covered withcovering 23, e.g., extending between atrial anchoring arms 46 to form anannular shape. It is hypothesized that this reduces a likelihood ofparavalvular leakage. For such embodiments, excess covering 23 may beprovided between atrial anchoring arms 46 of upstream support portion40, so as to facilitate their independent movement. Although FIG. 1Ashows covering 23 covering an upstream side of upstream support portion40, the covering may additionally or alternatively cover the downstreamside of the upstream support portion. For example, covering 23 mayextend over the tips of atrial anchoring arms 46 and down the outside ofthe arms, or a separate piece of covering may be provided on thedownstream side of the upstream support portion.

Alternatively, each atrial anchoring arm 46 may be individually coveredin a sleeve of covering 23, thereby facilitating independent movement ofthe arms.

For some embodiments, at least a portion of ventricular anchor support50 (e.g., ventricular anchoring legs 54 thereof) is covered withcovering 23.

In some embodiments, annular valve body 22 comprises a plurality ofventricular anchor supports 50 (e.g., two or more ventricular anchorsupports, e.g., 2-16 ventricular anchor supports, such as 4-12ventricular anchor supports, such as 6-12 ventricular anchor supports),arranged circumferentially around inner frame 30 (e.g., around theoutside of tubular portion 32). In some embodiments, annular valve body22 comprises a plurality of coupling points 52 at which the ventricularanchor supports are coupled to inner frame 30.

As described in more detail hereinbelow (e.g., with reference to FIG.3A), each ventricular anchor support 50 may be coupled to a couplingpoint 52 via a strut 70. For some embodiments, each ventricular anchorsupport 50 is coupled to a plurality of (e.g., two) coupling points 52via a respective plurality of (e.g., two) struts 70. For some suchembodiments, annular valve body 22 is arranged such that, in theexpanded state of the annular valve body, ventricular anchor support 50is disposed, circumferentially with respect to tubular portion 32,between two struts, and each of the two struts are disposed,circumferentially with respect to the tubular portion, between theventricular anchor support and a respective coupling point 52.

For some embodiments, a plurality of (e.g., two) ventricular anchorsupports 50 are coupled to each coupling point 52 via a respectiveplurality of (e.g., two) struts 70. For some such embodiments, annularvalve body 22 is arranged such that, in the expanded state of theannular valve body, coupling point 52 is disposed, circumferentiallywith respect to tubular portion 32, between two struts 70, and each ofthe two struts are disposed, circumferentially with respect to thetubular portion, between the coupling point and a respective ventricularanchor support 50.

For some embodiments, annular valve body 22 comprises an outer frame(e.g., a leg frame) 60 that circumscribes tubular portion 32, comprises(or defines) the plurality of ventricular anchoring supports 50 and theplurality of struts 70, and is coupled to inner frame 30 at theplurality of coupling points 52, such that the plurality of ventricularanchoring supports are distributed circumferentially around the tubularportion. For such embodiments, outer frame 60 comprises a ring 66 thatis defined by a pattern of alternating peaks 64 and troughs 62, and thatin some embodiments circumscribes tubular portion 32. For example, thering may comprise struts 70, extending between the peaks and troughs.Peaks 64 are longitudinally closer to upstream end 34 of tubular portion32 than to downstream end 36, and troughs 62 are longitudinally closerto the downstream end than to the upstream end. (It is to be noted thatthroughout this patent application, including the specification and theclaims, the term “longitudinally” means with respect to longitudinalaxis ax1. For example, “longitudinally closer” means closer along axisax1 (whether positioned on axis ax1 or lateral to axis ax1), and“longitudinal movement” means a change in position along axis ax1 (whichmay be in additional to movement toward or away from axis ax1).Therefore, peaks 64 are closer than troughs 62 to upstream end 34, andtroughs 62 are closer than peaks 64 to downstream end 36. Forembodiments in which frame 60 comprises ring 66, each ventricular anchorsupport 50 is coupled to the ring (or defined by frame 60) at arespective trough 62.

In the embodiment shown, the peaks and troughs are defined by ring 66having a generally zig-zag shape. However, the scope of the inventionincludes ring 66 having another shape that defines peaks and troughs,such as a serpentine or sinusoid shape.

For embodiments in which annular valve body 22 has a plurality ofcoupling points 52, the coupling points (and therefore coupling elements31 and 61) are disposed circumferentially around the annular valve body(e.g., around axis ax1), in some embodiments on a transverse plane thatis orthogonal to axis ax1. This transverse plane is illustrated by theposition of section A-A in FIG. 2B. Alternatively, coupling points 52may be disposed at different longitudinal heights of annular valve body22, e.g., such that different ventricular anchoring legs 54 arepositioned and/or moved differently to others. In some embodiments,coupling points 52 (and therefore coupling elements 31 and 61) aredisposed longitudinally between upstream end 24 and downstream end 26 ofannular valve body 22, but not at either of these ends. Further in someembodiments, coupling points 52 are disposed longitudinally betweenupstream end 34 and downstream end 36 of tubular portion 32, but not ateither of these ends. For example, the coupling points may be more than3 mm (e.g., 4-10 mm) both from end 34 and from end 36. It ishypothesized that this advantageously positions the coupling points at apart of tubular portion 32 that is more rigid than end 34 or end 36.

It is to be noted that ventricular anchor support 50 may be expandableinto its expanded state (e.g., a released-leg state) such thatventricular anchoring leg 54 extends away from axis ax1, independentlyof increasing the diameter of tubular portion 32 (e.g., as shown inFIGS. 2B & 2D). Similarly, upstream support portion 40 may be expandableinto its expanded state (e.g., a released-arm state) such that it (e.g.,arms 46 thereof) extends away from axis ax1, independently of increasingthe diameter of tubular portion 32 (e.g., as shown in FIGS. 2C & 2D).The state shown in FIG. 2D may be considered to be an intermediatestate. Therefore, implant 20 may be configured such that ventricularanchor supports 50 (e.g., ventricular anchoring legs 54 thereof) andupstream support portion 40 are expandable such that they both extendaway from axis ax1, while retaining a distance d3 therebetween. Thisdistance is subsequently reducible to a distance d4 by expanding tubularportion 32 (e.g., shown in FIG. 2E). By reducing distance d4 to distanced3, ventricular anchoring legs 54 and upstream support portion 40(including atrial anchoring arms 46) are configured to apply opposinggrasping forces upon tissue positioned therebetween, such as tissue ofthe native mitral valve.

For some embodiments, while tubular portion 32 remains in its compressedstate, leg 54 can extend away from axis ax1 over 40 percent (e.g., 40-80percent, such as 40-70 percent) of the distance that it extends from theaxis subsequent to the expansion of the tubular portion. For example,for embodiments in which implant 20 comprises a leg 54 on opposing sidesof the implant, a span d15 of the ventricular anchoring legs whiletubular portion 32 is in its compressed state may be at least 40 percent(e.g., 40-80 percent, such as 40-70 percent) as great as a span d16 ofthe ventricular anchoring legs subsequent to the expansion of thetubular portion. For some embodiments, span d15 is greater than 15 mmand/or less than 50 mm (e.g., 20-30 mm). For some embodiments, span d16is greater than 30 mm and/or less than 60 mm (e.g., 40-50 mm). It is tobe noted that leg 54 is effectively fully expanded, with respect toother portions of ventricular anchor support 50 and/or with respect totubular portion 32, before and after the expansion of the tubularportion.

Similarly, for some embodiments, while tubular portion 32 remains in itscompressed state, upstream support portion 40 (e.g., arms 46) can extendaway from axis ax1 over 30 percent (e.g., 30-70 percent) of the distancethat it extends from the axis subsequent to the expansion of the tubularportion. That is, for some embodiments, a span d17 of the upstreamsupport portion while tubular portion 32 is in its compressed state maybe at least 30 percent (e.g., 30-70 percent) as great as a span d18 ofthe upstream support portion subsequent to the expansion of the tubularportion. For some embodiments, span d17 is greater than 16 mm (e.g.,greater than 20 mm) and/or less than 50 mm (e.g., 30-40 mm). For someembodiments, span d18 is greater than 40 mm and/or less than 65 mm(e.g., 45-56 mm, such as 45-50 mm). It is to be noted that upstreamsupport portion 40 is effectively fully expanded, with respect totubular portion 32, before and after the expansion of the tubularportion.

It is to be noted that when tubular portion 32 is expanded, ventricularanchoring legs 54 may translate radially outward from span d15 to spand16 (e.g., without deflecting). In some embodiments, upstream supportportion 40 behaves similarly (e.g., arms 46 translated radially outwardfrom span d17 to span d18, e.g., without deflecting). That is, anorientation of each leg 54 and/or each arm 46 with respect to tubularportion 32 and/or axis ax1 may be the same in the state shown in FIG. 2Das it is in the state shown in FIG. 2E. Similarly, for some embodimentsan orientation of each leg 54 with respect to upstream support portion40 (e.g., with respect to one or more arms 46 thereof) is the samebefore and after expansion of tubular portion 32.

For some embodiments, increasing the diameter of tubular portion 32 fromd1 to d2 causes greater than 1 mm and/or less than 20 mm (e.g., 1-20 mm,such as 1-10 mm or 5-20 mm) of longitudinal movement of leg 54 away fromcoupling point 52. For some embodiments, increasing the diameter oftubular portion 32 from d1 to d2 causes greater than 1 mm and/or lessthan 20 mm (e.g., 1-20 mm, such as 1-10 mm or 5-20 mm) of longitudinalmovement of upstream support portion 40 toward coupling point 52. Forsome embodiments, distance d3 is 7-30 mm. For some embodiments, distanced4 is 0-15 mm (e.g., 2-15 mm). For some embodiments, increasing thediameter of tubular portion 32 from d1 to d2 reduces the distancebetween the upstream support portion and legs 54 by more than 5 mmand/or less than 30 mm, such as 5-30 mm (e.g., 10-30 mm, such as 10-20mm or 20-30 mm). For some embodiments, the difference between d3 and d4is generally equal to the difference between d1 and d2. For someembodiments, the difference between d3 and d4 is more than 1.2 and/orless than 3 times (e.g., 1.5-2.5 times, such as about 2 times) greaterthan the difference between d1 and d2.

For some embodiments, legs 54 curve such that a tip of each leg 54 isdisposed at a shallower angle with respect to inner region 42 ofupstream support portion 40, than are portions of ventricular anchorsupport 50 that are closer to downstream end 26 of annular valve body22. For some such embodiments, a tip of each leg may be generallyparallel with inner region 42. For some such embodiments, while tubularportion 32 is in its expanded state, a tip portion 55 of each leg 54that extends from the tip of the leg at least 2 mm along the leg, isdisposed within 2 mm of upstream support portion 40. Thus, for someembodiments, while tubular portion 32 is in its expanded state, for atleast 5 percent (e.g., 5-8 percent, or at least 8 percent) of span 18 ofupstream support portion 40, the upstream support portion is disposedwithin 2 mm of a leg 54.

For some embodiments, in the absence of any obstruction (such as tissueof the valve or covering 23) between leg 54 and upstream support portion40, increasing the diameter of tubular portion 32 from d1 to d2 causesthe leg 54 and the upstream support portion to move past each other(e.g., the leg 54 may move between arms 46 of the upstream supportportion), such that the leg 54 is closer to the upstream end of implant20 than is the upstream support portion, e.g., as shown hereinbelow forannular valve bodies 122 and 222, mutatis mutandis. (For embodiments inwhich upstream support portion 40 is covered by covering 23, legs 54 maynot pass the covering. For example, in the absence of any obstruction,legs 54 may pass between arms 46, and press directly against covering23.) It is hypothesized that for some embodiments this configurationapplies greater force to the valve tissue being sandwiched, and therebyfurther facilitates anchoring of the implant. That is, for someembodiments, distance d3 is smaller than the sum of distance d5 and adistance d14 (described with reference to FIG. 3C). For someembodiments, increasing the diameter of tubular portion 32 from d1 to d2advantageously causes legs 54 and upstream support portion 40 to movegreater than 3 mm and/or less than 25 mm (e.g., greater than 5 mm and/orless than 15 mm, e.g., 5-10 mm, such as about 7 mm) with respect to eachother (e.g., toward each other and then past each other).

In accordance with some embodiments of the present disclosure, and asdepicted in FIGS. 4A-5, implant 20 (“prosthetic valve 20”) may beconfigured for implantation within a native valve, such as a nativemitral valve. Prosthetic valve 20 may include annular valve body 22. Asillustrated in FIGS. 1A and 2A-2E, a plurality of arms 46 (“atrialanchoring arms 46”) and a plurality of ventricular anchoring legs 54 maybe configured to extend from annular valve body 22. Atrial anchoringarms 46 may include inner regions 42 (“inner portions 42”) and outerregions 44 (“outer portions 44”), with outer regions 44 positionedradially outward from inner regions 42. For example, inner regions 42may be situated within inner radial halves of atrial anchoring arms 46,as illustrated in FIGS. 1A and 2D.

In some embodiments, atrial anchoring arms 46 and ventricular anchoringlegs 54 may be configured to assume a delivery configuration (forexample, as depicted in FIG. 2A). In the delivery configuration, atrialanchoring arms 46 and ventricular anchoring legs 54 may be arrangedgenerally parallel with axis ax1. For example, atrial anchoring arms 46and ventricular anchoring legs 54 may be radially constrained in thedelivery configuration by a delivery device, such as delivery tool 89.Atrial anchoring arms 46 and ventricular anchoring legs 54 may also beconfigured to assume a deployed configuration (for example, as depictedin FIG. 2D). In the deployed configuration, atrial anchoring arms 46 andventricular anchoring legs 54 may be released such that they deflectradially outward from axis ax1 and thus from the delivery configuration.

In some embodiments, and as depicted in FIGS. 2A, 2C, and 2E, forexample, inner portions 42 of the atrial anchoring arms 46 may beconfigured as pivoting portions and may be configured to extend indifferent directions in the delivery and deployed configurations. Atrialanchoring arms 46, including inner portions 42, may be configured toextend in an atrial direction or, alternatively, in a non-ventriculardirection when in the delivery configuration. The term “atrialdirection” may refer to a direction extending upstream from prostheticvalve 20, towards an atrium of the heart. For example, in FIGS. 4A-4E,an “atrial direction” may refer to a direction extending upstream fromthe valve towards left atrium 6. The term “ventricular direction” mayrefer to a direction extending downstream from prosthetic valve 20,towards a ventricle of the heart. Thus, the term “non-ventriculardirection” may refer to any direction which does not extend towards aventricle of the heart; a “non-ventricular direction” may extend in anatrial direction, or it may extend laterally in a directionperpendicular to the ventricular direction. In some embodiments, an“atrial direction” may be angled radially inward or outward fromprosthetic valve 20, so long as it also is angled upstream (towards anatrium) and not downstream (towards a ventricle); that is, an “atrialdirection” need not necessarily be parallel to longitudinal axis ax1,although it may be parallel to longitudinal axis ax1 in someembodiments. Similarly, a “ventricular direction” may be angled radiallyinward or outward from prosthetic valve 20, so long as it also is angleddownstream, towards a ventricle. For example, in FIGS. 4A-4F, a“ventricular direction” may refer to a direction extending downstream(downwards in FIGS. 4A-4F) from the valve towards the left ventricle. A“ventricular direction” need not necessarily be parallel to longitudinalaxis ax1, although it may be parallel to longitudinal axis ax1 in someembodiments.

As described further below, inner portions 42 of the atrial anchoringarms may be configured to extend in a ventricular direction when theatrial anchoring arms 46 are in the deployed configuration. For example,inner portions 42 may deflect radially outward at an angle of 60-120degrees (e.g., 70-110 degrees) with respect to axis ax1 when the atrialanchoring arms are in the deployed configuration. In some embodiments,inner portions 42 deflect by an angle greater than 90 degrees whentransitioning from the delivery configuration to the deployedconfiguration; as a result, the inner portions 42 may extend in aventricular direction (i.e. downstream towards a ventricle) when theatrial anchoring arms are in the deployed configuration.

In some embodiments, and as depicted in FIGS. 2A, 2C, and 2E, forexample, outer portions 44 of the atrial anchoring arms 46 may beconfigured as upstanding portions and may be configured to extend in anon-ventricular direction when the atrial anchoring arms 46 are in boththe delivery configuration and the deployed configuration. Atrialanchoring arms 46, including outer portions 44, may be arranged parallelto axis ax1 and may extend in an atrial direction when in the deliveryconfiguration. As described further below, when atrial anchoring arms 46transition into the deployed configuration, outer portions 44 maydeflect radially outwards at an angle of 5-70 degrees with respect toaxis ax1, thus continuing to extend in an atria direction, and thus alsoin a non-ventricular direction.

In some embodiments, as depicted in FIGS. 2A and 2B, for example, atleast one ventricular anchoring leg 54 may be configured such that itsentire length may extend in an atrial direction or, alternatively, in anon-ventricular direction in both the delivery configuration and thedeployed configuration. With reference to FIGS. 3A-3C, the term “entirelength” may refer to the length extending from a point of intersectionbetween ventricular anchoring leg 54 and connectors 78, to the terminalend of ventricular anchoring leg 54. In the delivery configuration, theentire length of the at least one ventricular anchoring leg may bearranged parallel to axis ax1 and may extend upstream towards an atrium,that is, in an atrial direction. As explained further below, in someembodiments the entire length of the at least one ventricular anchoringleg may deflect radially outwards by less than 90 degrees with respectto longitudinal axis ax1 when transitioning from the deliveryconfiguration to the deployed configuration. As a result, the entirelength of the at least one ventricular anchoring leg may extend in anatrial direction and/or in a non-ventricular direction when in thedeployed configuration.

In some embodiments, in the expanded state of annular valve body 22,upstream support portion 40 has an inner region (e.g., an inner ring) 42that extends radially outward at a first angle with respect to axis ax1(and in some embodiments with respect to tubular portion 32), and anouter region (e.g., an outer ring) 44 that extends, from the innerregion, further radially outward from the tubular portion at a secondangle with respect to the tubular portion, the second angle beingsmaller than the first angle. For example, for some embodiments innerregion 42 extends radially outward at an angle alpha_1 of 60-120 degrees(e.g., 70-110 degrees) with respect to axis ax1, and outer region 44extends radially outward at an angle alpha_2 of 5-70 degrees (e.g.,10-60 degrees) with respect to axis ax1. In some embodiments, such asthe embodiments depicted in FIGS. 2A-2E, inner portions 42 may each beconfigured to deflect radially outward by the same angle with respect tolongitudinal axis ax1 and outer portions 44 may each be configured todeflect radially outward by the same angle with respect to longitudinalaxis ax1 such that the terminal ends of atrial anchoring arms 46 aresubstantially aligned in a common lateral plane when atrial anchoringarms 46 are in the deployed configuration (as depicted in FIGS. 2C and2D).

It is to be noted that angles alpha_1 and alpha_2 are measured betweenthe respective region support portion 40, and the portion of axis ax1that extends in an upstream direction from the level of annular valvebody 22 at which the respective region begins to extend radiallyoutward.

For some embodiments in which implant 20 is configured to be placed atan atrioventricular valve (e.g., a mitral valve or a tricuspid valve) ofthe subject, region 42 is configured to be placed against the upstreamsurface of the annulus of the atrioventricular valve, and region 44 isconfigured to be placed against the walls of the atrium upstream of thevalve.

For some embodiments, outer region 44 is more flexible than inner region42. For example, and as shown, each arm 46 may have a differentstructure in region 44 than in region 42. It is hypothesized that therelative rigidity of region 42 provides resistance against ventricularmigration of implant 20, while the relative flexibility of region 44facilitates conformation of upstream support portion 40 to the atrialanatomy.

For some embodiments, two or more of arms 46 are connected by aconnector (not shown), reducing the flexibility, and/or the independenceof movement of the connected arms relative to each other. For someembodiments, arms 46 are connected in particular sectors of upstreamsupport portion 40, thereby making these sectors more rigid than sectorsin which the arms are not connected. For example, a relatively rigidsector may be provided to be placed against the posterior portion of themitral annulus, and a relatively flexible sector may be provided to beplaced against the anterior side of the mitral annulus, so as to reduceforces applied by upstream support portion 40 on the aortic sinus.

For some embodiments, and as shown, coupling points 52 are disposedcloser to downstream end 26 of annular valve body 22 than areventricular anchoring legs 54, or is upstream support portion 40.

As described in more detail with respect to FIGS. 4A-F, the movement ofventricular anchoring leg 54 away from coupling point 52 (and thetypical movement of upstream support portion 40 toward the couplingpoint) facilitates the sandwiching of tissue of the native valve (e.g.,leaflet and/or annulus tissue) between the ventricular anchoring leg 54and the upstream support portion, thereby securing implant 20 at thenative valve.

In some embodiments, in the compressed state of tubular portion 32, adownstream end of each ventricular anchor support 50 is longitudinallycloser than valve-frame coupling elements 31 to downstream end 36, andventricular anchoring leg 54 of each ventricular anchor support 50 isdisposed longitudinally closer than the valve-frame coupling elements toupstream end 34. In some embodiments, this is also the case in theexpanded state of tubular portion 32.

FIGS. 3A-C show structural changes in annular valve body 22 duringtransitioning of the annular valve body between its compressed andexpanded states, in accordance with some embodiments of the invention.FIGS. 3A-C each show a portion of the annular valve body, the structuralchanges thereof being representative of the structural changes thatoccur in other portions of the annular valve body. FIG. 3A shows aventricular anchor support 50 and struts 70 (e.g., a portion of outerframe 60), and illustrates the structural changes that occur aroundouter frame 60. FIG. 3B shows a portion of inner frame 30, andillustrates the structural changes that occur around the inner frame.FIG. 3C shows inner frame 30 as a whole. In each of FIGS. 3A-C, state(A) illustrates the structure while annular valve body 22 (and inparticular tubular portion 32) is in its compressed state, and state (B)illustrates the structure while the annular valve body (and inparticular tubular portion 32) is in its expanded state.

FIG. 3A shows structural changes in the coupling of ventricularanchoring supports 50 to coupling point 52 (e.g., structural changes ofouter frame 60) during the transitioning of annular valve body 22 (andin particular tubular portion 32) between its compressed and expandedstates. Each ventricular anchor support 50 is coupled to inner frame 30via at least one strut 70, which connects the ventricular anchoringsupport to coupling point 52. In some embodiments, each ventricularanchor support 50 is coupled to inner frame 30 via a plurality of struts70. A first end 72 of each strut 70 is coupled to ventricular anchorsupport 50, and a second end 74 of each strut is coupled to a couplingpoint 52. As described hereinabove, for embodiments in which frame 60comprises ring 66, each ventricular anchor support 50 is coupled to thering at a respective trough 62. Ring 66 may comprise struts 70,extending between the peaks and troughs, with each first end 72 at (orclose to) a trough 62, and each second end 74 at (or close to) a peak64.

In the compressed state of annular valve body 22 (and in particular oftubular portion 32), each strut 70 is disposed at a first angle in whichfirst end 72 is disposed closer than second end 74 to the downstream endof the annular valve body. Expansion of annular valve body 22 (and inparticular of tubular portion 32) toward its expanded state causes strut70 to deflect to a second angle. This deflection moves first end 72 awayfrom the downstream end of annular valve body 22. That is, in theexpanded state of annular valve body 22, first end 72 is further fromthe downstream end of the annular valve body than it is when the annularvalve body is in its compressed state. This movement is shown as adistance d5 between the position of end 72 in state (A) and its positionin state (B). This movement causes the above-described movement ofventricular anchoring legs 54 away from coupling points 52. As shown,ventricular anchoring legs 54 in some embodiments move the same distanced5 in response to expansion of annular valve body 22.

For embodiments in which outer frame 60 comprises ring 66, the patternof alternating peaks and troughs may be described as having an amplitudelongitudinally between the peaks and troughs, i.e., measured parallelwith central longitudinal axis ax1 of annular valve body 22, and thetransition between the compressed and expanded states may be describedas follows: In the compressed state of annular valve body 22 (and inparticular of tubular portion 32), the pattern of ring 66 has anamplitude d20. In the expanded state annular valve body 22 (and inparticular of tubular portion 32), the pattern of ring 66 has anamplitude d21 that is lower than amplitude d20. Because (i) it is atpeaks 64 that ring 66 is coupled to inner frame 30 at coupling points52, and (ii) it is at troughs 62 that ring 66 is coupled to ventricularanchoring supports 50, this reduction in the amplitude of the pattern ofring 66 moves ventricular anchoring supports 50 (e.g., ventricularanchoring legs 54 thereof) longitudinally further from the downstreamend of the annular valve body. The magnitude of this longitudinalmovement (e.g., the difference between magnitudes d20 and d21) is equalto d5.

In some embodiments, distance d5 is the same distance as the distancethat ventricular anchoring leg 54 moves away from coupling point 52during expansion of the annular valve body. That is, a distance betweenventricular anchoring leg 54 and the portion of ventricular anchorsupport 50 that is coupled to strut 70, in some embodiments remainsconstant during expansion of the annular valve body. For someembodiments, the longitudinal movement of ventricular anchoring leg 54away from coupling point 52 is a translational movement (e.g., amovement that does not include rotation or deflection of the ventricularanchoring leg 54).

For some embodiments, a distance d6, measured parallel to axis ax1 ofannular valve body 22, between coupling point 52 and first end 72 ofstrut 70 while annular valve body 22 is in its compressed state, is 3-15mm. For some embodiments, a distance d7, measured parallel to axis ax1,between coupling point 52 and first end 72 of strut 70 while annularvalve body 22 is in its expanded state, is 1-5 mm (e.g., 1-4 mm).

For some embodiments, amplitude d20 is 2-10 mm (e.g., 4-7 mm). For someembodiments, amplitude d21 is 4-9 mm (e.g., 5-7 mm).

For some embodiments, and as shown, in the expanded state, first end 72of strut 70 is disposed closer to the downstream end of annular valvebody 22 than is coupling point 52. For some embodiments, in the expandedstate, first end 72 of strut 70 is disposed further from the downstreamend of annular valve body 22 than is coupling point 52.

For embodiments in which annular valve body 22 comprises a plurality ofventricular anchoring supports 50 and a plurality of coupling points 52(e.g., for embodiments in which the annular valve body comprises outerframe 60) expansion of the annular valve body increases acircumferential distance between adjacent coupling points 52, and anincrease in a circumferential distance between adjacent ventricularanchoring supports 50. FIG. 3A shows such an increase in thecircumferential distance between adjacent coupling points 52, from acircumferential distance d8 in the compressed state to a circumferentialdistance d9 in the expanded state. For some embodiments, distance d8 is1-6 mm. For some embodiments, distance d9 is 3-15 mm.

For some embodiments, in addition to being coupled via ring 66 (e.g.,struts 70 thereof) ventricular anchoring supports 50 are also connectedto each other via connectors 78. Connectors 78 allow the describedmovement of ventricular anchoring supports 50 during expansion ofannular valve body 22, but in some embodiments stabilize ventricularanchoring supports 50 relative to each other while the annular valvebody is in its expanded state. For example, connectors 78 may bendand/or deflect during expansion of the annular valve body. According tothe embodiments depicted in FIGS. 1B and 3A, each ventricular anchoringleg 54 may extend from and be connected to a single portion of outerframe 60. Specifically, each ventricular anchoring leg 54 may connectto, and extend from, a point of intersection between ventricularanchoring leg 54 and connectors 78. In addition, no ventricularanchoring legs 54 share a connection point to outer frame 60. That is,each ventricular anchoring leg 54 may extend from a separate part ofouter frame 60.

FIGS. 3B-C show structural changes in inner frame 30 during thetransitioning of annular valve body 22 between its compressed andexpanded states. Tubular portion 32 of inner frame 30 is defined by aplurality of cells 80, which are defined by the repeating pattern of theinner frame. When annular valve body 22 is expanded from its compressedstate toward its expanded state, cells 80 (i) widen from a width d1 0 toa width d11 (measured orthogonal to axis ax1 of the annular valve body),and (ii) shorten from a height d12 to a height d13 (measured parallel toaxis ax1 of the annular valve body). This shortening reduces the overallheight (i.e., a longitudinal length between upstream end 34 anddownstream end 36) of tubular portion 32 from a height d22 to a heightd23, and thereby causes the above-described longitudinal movement ofupstream support portion 40 toward coupling points 52 by a distance d14(shown in FIG. 3C). For some embodiments, and as shown, coupling points52 are disposed at the widest part of each cell. According to someembodiments, and as depicted in FIG. 3B, for example, because acircumferential distance between adjacent coupling elements 31 may beequal for all coupling elements 31 (e.g., d11), a circumferentialdistance between adjacent arms 46 (“atrial anchoring arms 46”) may alsobe equal for all atrial anchoring arms 46, as each anchoring arm 46 isdisposed between two adjacent coupling elements 31. Thus, atrialanchoring arms 46 may be configured to be spaced at a regular intervalabout a circumference of annular valve body 22.

Due to the configurations described herein, the distance by whichventricular anchoring legs 54 move with respect to (e.g., toward, ortoward-and-beyond) upstream support portion 40 (e.g., arms 46 thereof),may be greater than the reduction in the overall height of tubularportion 32 (e.g., more than 20 percent greater, such as more than 30percent greater, such as more than 40 percent greater). That is, implant20 comprises: a inner frame (30) that comprises a tubular portion (32)that circumscribes a longitudinal axis (ax1) of the inner frame so as todefine a lumen (38) along the axis, the tubular portion having anupstream end (34), a downstream end (36), a longitudinal lengththerebetween, and a diameter (e.g., d1 or d2) transverse to thelongitudinal axis; a valve member (58), coupled to the tubular portion,disposed within the lumen, and arranged to provide unidirectionalupstream-to-downstream flow of blood through the lumen; an upstreamsupport portion (40), coupled to the tubular portion; and an outer frame(60), coupled to the tubular portion, and comprising a ventricularanchoring leg (54), wherein: the implant has a first state (e.g., asshown in FIG. 2D and FIG. 4D) and a second state (e.g., as shown in FIG.2E and FIG. 4E), in both the first state and the second state, (i) theupstream support portion extends radially outward from the tubularportion, and (ii) the ventricular anchoring leg 54 extends radiallyoutward from the tubular portion, and the tubular portion, the upstreamsupport portion, and the outer frame are arranged such thattransitioning of the implant from the first state toward the secondstate: increases the diameter of the tubular portion by adiameter-increase amount (e.g., the difference between d1 and d2),decreases the length of the tubular portion by a length-decrease amount(e.g., the difference between d22 and d23), and moves the ventricularanchoring leg 54 a longitudinal distance with respect to (e.g., towardor toward-and-beyond) the upstream support portion (e.g., the differencebetween d3 and d4), this distance being greater than the length-decreaseamount.

As shown in the figures, inner frame 30 may be coupled to outer frame 60by coupling between (i) a valve-frame coupling element 31 defined byinner frame 30, and (ii) an outer-frame coupling element 61 defined byouter frame 60 (e.g., an outer-frame coupling element is coupled to end74 of each strut). In some embodiments, elements 31 and 61 are fixedwith respect to each other. Each coupling point 52 may be defined as thepoint at which a valve-frame coupling element and a correspondingouter-frame coupling element 61 are coupled (e.g., are fixed withrespect to each other). For some embodiments, and as shown, elements 31and 61 are eyelets configured to be coupled together by a connector,such as a pin or suture. For some embodiments, elements 31 and 61 aresoldered or welded together.

In some embodiments, and as shown, valve-frame coupling elements 31 aredefined by tubular portion 32, and are disposed circumferentially aroundcentral longitudinal axis ax1. Outer-frame coupling elements 61 arecoupled to ring 66 (or defined by frame 60, such as by ring 66) atrespective peaks 64.

As shown (e.g., in FIGS. 2A-E), inner frame 30 (e.g., tubular portion 32thereof) and outer frame 60 (e.g., ring 66 thereof) are arranged in aclose-fitting coaxial arrangement, in both the expanded and compressedstates of annular valve body 22. Ignoring spaces due to the cellularstructure of the frames, a radial gap d19 between inner frame 30 (e.g.,tubular portion 32 thereof) and outer frame 60 (e.g., ring 66 thereof)may be less than 2 mm (e.g., less than 1 mm), in both the compressed andexpanded states, and during the transition therebetween. This isfacilitated by the coupling between frames 30 and 60, and the behavior,described hereinabove, of frame 60 in response to changes in thediameter of tubular portion 32 (e.g., rather than solely due to deliverytechniques and/or tools). For some embodiments, more than 50 percent(e.g., more than 60 percent) of ring 66 is disposed within 2 mm oftubular portion 32 in both the compressed and expanded states, andduring the transition therebetween. For some embodiments, more than 50percent (e.g., more than 60 percent) of outer frame 60, except forventricular anchoring legs 54, is disposed within 2 mm of tubularportion 32 in both the compressed and expanded states, and during thetransition therebetween. In some embodiments in which annular valve body22 and legs 54 (“ventricular anchoring legs 54”) are in a compressedstate (a “delivery configuration”), as depicted in FIGS. 2A, 7A, and 8A,for example, at least one ventricular anchoring leg 54 may be configuredsuch that its entire length is substantially flush with inner frame 30due to the small distance d19 between inner frame 30 and outer frame 60,and due to the fact that anchoring legs 54 may be arranged generallyparallel with axis ax1. As a result, the at least one ventricularanchoring leg 54 may be configured to abut a portion of inner frame 30.

The structural changes to annular valve body 22 (e.g., to outer frame 60thereof) are described hereinabove as they occur during (e.g., as aresult of) expansion of the annular valve body (in particular tubularportion 32 thereof). This is the natural way to describe these changesbecause, as described hereinbelow with respect to FIGS. 4A-6, annularvalve body 22 is in its compressed state during percutaneous delivery tothe implant site, and is subsequently expanded. However, the nature ofimplant 20 may be further understood by describing structural changesthat occur during compression of the annular valve body (e.g., atransition from the expanded state in FIG. 2E to the intermediate statein FIG. 2D), in particular tubular portion 32 thereof (including iftubular portion 32 were compressed by application of compressive forceto the tubular portion, and not to frame 60 except via the tubularportion pulling frame 60 radially inward). Such descriptions may also berelevant because implant 20 may be compressed (i.e., “crimped”) soonbefore its percutaneous delivery, and therefore these changes may occurwhile implant 20 is in the care of the operating physician.

For some embodiments, the fixation of peaks 64 to respective sites oftubular portion 32 is such that compression of the tubular portion fromits expanded state toward its compressed state such that the respectivesites of the tubular portion pull the peaks radially inward viaradially-inward tension on coupling points 52: (i) reduces acircumferential distance between each of the coupling points and itsadjacent coupling points (e.g., from d9 to d8), and (ii) increases theamplitude of the pattern of ring 66 (e.g., from d21 to d20).

For some embodiments, the fixation of outer-frame coupling elements 61to valve-frame coupling elements 31 is such that compression of tubularportion 32 from its expanded state toward its compressed state such thatthe valve-frame coupling elements pull the outer-frame coupling elementsradially inward: (i) reduces a circumferential distance between each ofthe outer-frame coupling elements and its adjacent outer-frame couplingelements (e.g., from d9 to d8), and (ii) increases the amplitude of thepattern of ring 66 (e.g., from d21 to d20).

For some embodiments, the fixation of peaks 64 to the respective sitesof tubular portion 32 is such that compression of the tubular portionfrom its expanded state toward its compressed state (i) pulls the peaksradially inward via radially-inward pulling of the respective sites ofthe tubular portion on the peaks, (ii) reduces a circumferentialdistance between each of coupling points 52 and its adjacent couplingpoints (e.g., from d9 to d8), and (iii) increases the amplitude of thepattern of ring 66 (e.g., from d21 to d20), without increasing radialgap d19 between inner frame 30 (e.g., tubular portion 32 thereof) andthe ring by more than 1.5 mm.

For some embodiments, the fixation of outer-frame coupling elements 61with respect to valve-frame coupling elements 31 is such thatcompression of tubular portion 32 from its expanded state toward itscompressed state (i) pulls outer-frame coupling elements 61 radiallyinward via radially-inward pulling of valve-frame coupling elements 31on outer-frame coupling elements 61, (ii) reduces a circumferentialdistance between each of the outer-frame coupling elements and itsadjacent outer-frame coupling elements (e.g., from d9 to d8), and (iii)increases the amplitude of the pattern of ring 66 (e.g., from d21 tod20), without increasing radial gap d19 between inner frame 30 (e.g.,tubular portion 32 thereof) and the ring by more than 1.5 mm.

Reference is made to FIGS. 4A-F, which are schematic illustrations ofimplantation of implant 20 at a native valve 10 of a heart 4 of asubject, in accordance with some embodiments of the invention. Valve 10is shown as a mitral valve of the subject, disposed between a leftatrium 6 and a left ventricle 8 of the subject. However implant 20 maybe implanted at another heart valve of the subject, mutatis mutandis.Similarly, although FIGS. 4A-F show implant 20 being deliveredtransseptally via a sheath 88, the implant may alternatively bedelivered by any other suitable route, such as transatrially, ortransapically.

Implant 20 is delivered, in its compressed state, to native valve 10using a delivery tool 89 that is operable from outside the subject (FIG.4A). In some embodiments, implant 20 is delivered within a deliverycapsule 90 of tool 89, which retains the implant in its compressedstate. A transseptal approach, such as a transfemoral approach, isshown. In some embodiments, implant 20 is positioned such that at leastventricular anchoring legs 54 are disposed downstream of the nativevalve (i.e., within ventricle 8). At this stage, annular valve body 22of implant 20 is as shown in FIG. 2A.

Subsequently, ventricular anchoring legs 54 are allowed to protruderadially outward, as described hereinabove, e.g., by releasing them fromcapsule 90 (FIG. 4B). For example, and as shown, capsule 90 may comprisea distal capsule-portion 92 and a proximal capsule-portion 94, and thedistal capsule-portion may be moved distally with respect to implant 20,so as to expose ventricular anchoring legs 54. At this stage, annularvalve body 22 of implant 20 is as shown in FIG. 2B.

Subsequently, implant 20 is moved upstream, such that upstream supportportion 40, in its compressed state, is disposed upstream of leaflets 12(i.e., within atrium 6). For some embodiments, the upstream movement ofimplant 20 causes ventricular anchoring legs 54 to engage leaflets 12.However, because of the relatively large distance d3 provided by implant20 (described hereinabove), for some embodiments it is not necessary tomove the implant so far upstream that ventricular anchoring legs 54tightly engage leaflets 12 and/or pull the leaflets upstream of thevalve annulus. Upstream support portion 40 is then allowed to expandsuch that it protrudes radially outward, as described hereinabove, e.g.,by releasing it from capsule 90 (FIG. 4D). For example, and as shown,proximal capsule-portion 94 may be moved proximally with respect toimplant 20, so as to expose upstream support portion 40. At this stage,annular valve body 22 of implant 20 is as shown in FIG. 2D, in which:(i) distance d3 exists between upstream support portion 40 andventricular anchoring legs 54, (ii) the ventricular anchoring legs havespan d15, (iii) the upstream support portion has span d17, and (iv)tubular portion 32 has diameter d1 .

In some embodiments, expansion of annular valve body 22 is inhibited bydistal capsule-portion 92 (e.g., by inhibiting expansion of tubularportion 32), and/or by another portion of delivery tool 89 (e.g., aportion of the delivery tool that is disposed within lumen 38).

Subsequently, implant 20 is allowed to expand toward its expanded state,such that tubular portion 32 widens to diameter d2, and the distancebetween upstream support portion 40 and ventricular anchoring legs 54reduces to distance d4 (FIG. 4E). This sandwiches tissue of valve 10 (insome embodiments including annular tissue and/or leaflets 12) betweenupstream support portion 40 and ventricular anchoring legs 54, therebysecuring implant 20 at the valve. FIG. 4F shows delivery capsule 90having been removed from the body of the subject, leaving implant 20 inplace at valve 10.

As described hereinabove, implant 20 is configured such that whentubular portion 32 is expanded, ventricular anchoring legs 54 andupstream support portion 40 move a relatively large distance toward eachother. This enables distance d3 to be relatively large, while distanced4 is sufficiently small to provide effective anchoring. As alsodescribed hereinabove, implant 20 is configured such that ventricularanchoring legs 54 and upstream support portion 40 can extend radiallyoutward a relatively large distance while tubular portion 32 remainscompressed. It is hypothesized that for some embodiments, theseconfigurations (independently and/or together) facilitate effectiveanchoring of implant 20, by facilitating placement of a relatively largeproportion of valve tissue (e.g., leaflets 12) between the ventricularanchoring legs 54 and the upstream support portion prior to expandingtubular portion 32 and sandwiching the valve tissue.

It is further hypothesized that the relatively great radially-outwardextension of ventricular anchoring legs 54 and upstream support portion40 prior to expansion of tubular portion 32, further facilitates theanchoring/sandwiching step by reducing radially-outward pushing of thevalve tissue (e.g., leaflets 12) during the expansion of the tubularportion, and thereby increasing the amount of valve tissue that issandwiched.

It is yet further hypothesized that this configuration of implant 20facilitates identifying correct positioning of the implant (i.e., withupstream support portion 40 upstream of leaflets 12 and ventricularanchoring legs 54 downstream of the leaflets) prior to expanding tubularportion 32 and sandwiching the valve tissue.

As shown in FIG. 1A, for some embodiments, in the expanded state ofannular valve body 22, implant 20 defines a toroidal space 49 betweenventricular anchoring legs 54 and upstream support portion 40 (e.g., aspace that is wider than distance d4). For example, space 49 may have agenerally triangular cross-section. It is hypothesized that for somesuch embodiments, in addition to sandwiching tissue of the native valvebetween upstream support portion 40 and ventricular anchoring legs 54(e.g., the tips of the legs), space 49 advantageously promotes tissuegrowth therewithin (e.g., between leaflet tissue and covering 23), whichover time further secures implant 20 within the native valve.

Reference is now made to FIG. 5, which is a schematic illustration of astep in the implantation of implant 20, in accordance with someembodiments of the invention. Whereas FIGS. 4A-F show an implantationtechnique in which ventricular anchoring legs 54 are expanded prior toupstream support portion 40, for some embodiments the upstream supportportion is expanded prior to the ventricular anchoring legs 54. FIG. 5shows a step in such an embodiment.

Reference is again made to FIGS. 2A-5. As noted hereinabove, implant 20may be implanted by causing ventricular anchoring legs 54 to radiallyprotrude before causing upstream support portion 40 to radiallyprotrude, or may be implanted by causing the upstream support portion toprotrude before causing the ventricular anchoring legs 54 to protrude.For some embodiments, implant 20 is thereby configured to be deliverablein a downstream direction (e.g., transseptally, as shown, ortransapically) or in an upstream direction (e.g., transapically or viathe aortic valve). Thus, for some embodiments, an operating physicianmay decide which delivery route is preferable for a given application(e.g., for a given subject, and/or based on available equipment and/orexpertise), and implant 20 is responsively prepared for the chosendelivery route (e.g., by loading the implant into an appropriatedelivery tool).

It is to be noted that for some embodiments, downstream delivery ofimplant 20 may be performed by expanding ventricular anchoring legs 54first (e.g., as shown in FIGS. 4A-F) or by expanding upstream supportportion 40 first (e.g., as shown in FIG. 5). Similarly, for someembodiments upstream delivery of implant 20 may be performed by upstreamsupport portion 40 first, or by expanding ventricular anchoring legs 54first.

Reference is now made to FIG. 6, which is a schematic illustration ofimplant 20, in the state and position shown in FIG. 4D, in accordancewith some embodiments of the invention. For some embodiments, whileimplant 20 is in the state and position shown in FIG. 4D, leaflets 12 ofvalve 10 are able to move, at least in part in response to beating ofthe heart. Frame (A) shows leaflets 12 during ventricular systole, andframe (B) shows the leaflets during ventricular diastole. For some suchembodiments, blood is thereby able to flow from atrium 6 to ventricle 8,between leaflets 12 and implant 20. It is hypothesized that thisadvantageously facilitates a more relaxed implantation procedure, e.g.,facilitating retaining of implant 20 in this state and position for aduration of greater than 8 minutes. During this time, imaging techniquesmay be used to verify the position of implant 20, and/or positioning ofleaflets 12 between upstream support portion 40 and legs 54.

Reference is made to FIGS. 7A-B and 8A-B, which are schematicillustrations of annular valve bodies 122 and 222 of respectiveimplants, in accordance with some embodiments of the invention. Exceptwhere noted otherwise, annular valve bodies 122 and 222 are in someembodiments identical to annular valve body 22, mutatis mutandis.Elements of annular valve bodies 122 and 222 share the name ofcorresponding elements of annular valve body 22. Additionally, exceptwhere noted otherwise, the implants to which annular valve bodies 122and 222 belong are similar to implant 20, mutatis mutandis.

Annular valve body 122 comprises (i) a inner frame 130 that comprises atubular portion 132 and an upstream support portion 140 that in someembodiments comprises a plurality of arms 146, and (ii) an outer frame(e.g., a leg frame) 160 that circumscribes the inner frame, andcomprises a plurality of ventricular anchoring supports 150 that eachcomprise a ventricular anchoring leg 154. In some embodiments,ventricular anchoring leg 154 may include an opening therein, such asnear its terminal end, as depicted in FIGS. 7A-8B, for example. In someembodiments, outer frame 160 comprises a ring 166 to which ventricularanchoring supports 150 are coupled. Ring 166 is defined by a pattern ofalternating peaks and troughs, the peaks being fixed to frame 130 atrespective coupling points 152, e.g., as described hereinabove forannular valve body 22, mutatis mutandis.

Annular valve body 222 comprises (i) a inner frame 230 that comprises atubular portion 232 and an upstream support portion 240 that in someembodiments comprises a plurality of arms 246, and (ii) an outer frame(e.g., a leg frame) 260 that circumscribes the inner frame, andcomprises a plurality of ventricular anchoring supports 250 that eachcomprise a ventricular anchoring leg 254. In some embodiments, outerframe 260 comprises a ring 266 to which ventricular anchoring supports250 are coupled. Ring 266 is defined by a pattern of alternating peaksand troughs, the peaks being fixed to frame 230 at respective couplingpoints 252, e.g., as described hereinabove for annular valve body 22,mutatis mutandis.

Whereas arms 46 of annular valve body 22 are shown as extending fromupstream end 34 of tubular portion 32, arms 146 and 246 of annular valvebodies 122 and 222, respectively, extend from sites further downstream.(This difference may also be made to annular valve body 22, mutatismutandis.) Tubular portions 32, 132 and 232 are each defined by arepeating pattern of cells that extends around the central longitudinalaxis. In some embodiments, and as shown, tubular portions 32, 132 and232 are each defined by two stacked, tessellating rows of cells. In theexpanded state of each tubular portion, these cells may be narrower attheir upstream and downstream extremities than midway between theseextremities. For example, and as shown, the cells may be roughly diamondor astroid in shape. In annular valve body 22, each arm 46 is attachedto and extends from a site 35 that is at the upstream extremity of cellsof the upstream row. In contrast, in annular valve bodies 122 and 222,each arm 146 or 246 is attached to and extends from a site 135 (annularvalve body 122) or 235 (annular valve body 222) that is at theconnection between two adjacent cells of the upstream row (alternativelydescribed as being at the upstream extremity of cells of the downstreamrow).

It is hypothesized by the inventors that this lower position of thearms, while maintaining the length of the lumen of the tubular portion,advantageously reduces the distance that the tubular portion (i.e., thedownstream end thereof) extends into the ventricle of the subject, andthereby reduces a likelihood of inhibiting blood flow out of theventricle through the left ventricular outflow tract. It is furtherhypothesized that this position of the arms reduces radial compressionof the tubular portion by movement of the heart, due to greater rigidityof the tubular portion at sites 135 and 235 (which is supported by twoadjacent cells) than at site 35 (which is supported by only one cell).

As shown, in the expanded state of annular valve bodies 22, 122 and 222,the ventricular anchoring supports (50, 150 and 250, respectively) arecircumferentially staggered with the arms of the upstream supportportion (46, 146 and 246, respectively). This allows the ventricularanchoring supports to move in an upstream direction between the armsduring expansion of the tubular portion (32, 132 and 232, respectively),facilitating application of greater sandwiching force on tissue of thenative valve. The lower position of the arms of annular valve bodies 122and 222 includes circumferentially shifting the position of the arms bythe width of half a cell. In order to maintain the circumferentialstaggering of the atrial anchoring arms 46, 146, 246 and ventricularanchoring legs 54, 154, 254, rings 166 and 266 (and thereby ventricularanchoring supports 150 and 250) are circumferentially shiftedcorrespondingly. As a result, whereas the peaks of ring 66 generallyalign with connections between adjacent cells of the downstream row ofcells of tubular portion 32 (and are fixed to these sites), the peaks ofrings 166 and 266 are generally aligned midway between these sites(i.e., at spaces of the cellular structure of the tubular portion). Anappendages 168 (for annular valve body 122) or 268 (for annular valvebody 222) facilitate fixing of the peak with respect to the tubularstructure.

For annular valve body 122, appendages 168 are defined by inner frame130 (e.g., by tubular portion 132 thereof) and extend (in a downstreamdirection) to the peaks of ring 166, to which they are fixed. Forexample, each appendage 168 may define a valve-frame coupling element131 that is fixed to a respective outer-frame coupling element 161defined by outer frame 260. In some embodiments, appendages 168 extendfrom sites 135. In some embodiments, appendages 168 are integral withtubular portion 132 and/or in-plane with the tubular portion (e.g., arepart of its tubular shape).

For annular valve body 222, appendages 268 are defined by outer frame260, and extend (e.g., in an upstream direction) from the peaks of ring266. In some embodiments, appendages 268 extend to sites 235, to whichthey are fixed. For example, each appendage 268 may define anouter-frame coupling element 261 that is fixed to a respectivevalve-frame coupling element 231 defined by inner frame 230 (e.g., bytubular portion 232 thereof). In some embodiments, appendages 268 areintegral with outer frame 260 and/or in-plane with adjacent portions ofouter frame 260, such as ring 266.

Therefore, annular valve body 122 defines a hub at site 135, and annularvalve body 222 defines a hub at site 235. For some embodiments,apparatus therefore comprises: a plurality of prosthetic valve leaflets;and a annular valve body, comprising: a tubular portion (132 or 232)defined by a repeating pattern of cells, the tubular portion extendingcircumferentially around longitudinal axis ax1 so as to define alongitudinal lumen, the prosthetic valve leaflets coupled to the innerframe and disposed within the lumen; an outer frame (160 or 260),comprising a plurality of ventricular anchoring supports (150 or 250),distributed circumferentially around the tubular portion, each supporthaving a ventricular anchoring leg (154 or 254); an upstream supportportion (140 or 240) that comprises a plurality of arms (146 or 246)that extend radially outward from the tubular portion; and a pluralityof appendages (168 or 268), each having a first end that defines acoupling element (161 or 261) via which the tubular portion is coupledto the outer frame, and a second end; wherein the annular valve bodydefines a plurality of hubs (135 or 235), distributed circumferentiallyaround the longitudinal axis on a plane that is transverse tolongitudinal axis ax1, each hub defined by convergence and connectionof, (i) two adjacent cells of the tubular portion, (ii) an arm of theplurality of arms, and (iii) an appendage of the plurality ofappendages.

Reference is made to FIGS. 9A-C, which are schematic illustrations of animplant 320 comprising a annular valve body 322, in accordance with someembodiments of the invention. Except where noted otherwise, annularvalve body 322 is identical to annular valve body 122, and implant 300is identical to the implant to which annular valve body 122 belongs,mutatis mutandis. FIG. 9A is a side-view of implant 320, and FIG. 9B isan isometric bottom-view of the implant.

Annular valve body 122 comprises (i) a inner frame 330 that comprises atubular portion 332 and an upstream support portion 340 that in someembodiments comprises a plurality of arms 346, and (ii) an outer frame(e.g., a leg frame) 360 that circumscribes the inner frame, andcomprises a plurality of ventricular anchoring supports 350 that eachcomprise a ventricular anchoring leg 354. In some embodiments, outerframe 360 comprises a ring 366 to which ventricular anchoring supports350 are coupled. Ring 366 is defined by a pattern of alternating peaksand troughs, the peaks being fixed to frame 330 at respective couplingpoints 352, e.g., as described hereinabove for annular valve body 22and/or annular valve body 122, mutatis mutandis.

Annular valve body 322 comprises an annular upstream support portion 340that has an inner portion 342 that extends radially outward from theupstream portion (e.g., the upstream end) of tubular portion 332.Upstream support portion 340 further comprises one or more fabricpockets 344 disposed circumferentially around inner portion 342, eachpocket of the one or more pockets having an opening that faces adownstream direction (i.e., generally toward the downstream end ofimplant 320). In the figures, upstream support portion 340 has a singletoroidal pocket 344 that extends circumferentially around inner portion342.

In some embodiments, a covering 323 (e.g., similar to covering 23,described hereinabove, mutatis mutandis) is disposed over arms 346,thereby forming pocket 344. Further in some embodiments, arms 346 areshaped to form pocket 344 from covering 323. For example, and as shown,arms 346 may curve to form a hook-shape.

For some embodiments, portion 340 has a plurality of separate pockets344, e.g., separated at arms 346. For some such embodiments, covering323 is loosely-fitted (e.g., baggy) between radially-outward parts ofarms 346, e.g., compared to inner portion 342, in which the covering ismore closely-fitted between radially-inward parts of the arms.

FIG. 9C shows implant 320 implanted at native valve 10. Pocket 344 maybe shaped and arranged to billow in response to perivalvular flow 302 ofblood in an upstream direction. If ventricular systole forces blood inventricle 8 between implant 320 and native valve 10, that blood inflatespocket 344 and presses it (e.g., covering 323 and/or theradially-outward part of arm 346) against tissue of atrium 6 (e.g.,against the atrial wall), thereby increasing sealing responsively. It ishypothesized by the inventors that the shape and orientation of pocket344 (e.g., the hook-shape of arms 346) facilitates this pressingradially-outward in response to the pocket's receipt of upstream-flowingblood.

Pocket(s) 344 may be used in combination with any of the implantsdescribed herein, mutatis mutandis.

Reference is again made to FIGS. 1A-9C. It is to be noted that unlessspecifically stated otherwise, the term “radially outward” (e.g., usedto describe upstream support portion 40 and ventricular anchoring legs54) means portions of the element are disposed progressively furtheroutward from a central point (such as longitudinal axis ax1 or tubularportion 32), but does not necessarily mean disposed at 90 degrees withrespect to longitudinal axis ax1. For example, ventricular anchoringlegs 54 may extend radially outward at 90 degrees with respect tolongitudinal axis ax1, but may alternatively extend radially outward ata shallower angle with respect to the longitudinal axis.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather, the scope of the present inventionincludes both combinations and subcombinations of the various featuresdescribed hereinabove, as well as variations and modifications thereofthat are not in the prior art, which would occur to persons skilled inthe art upon reading the foregoing description.

1-72. (canceled)
 73. A prosthetic heart valve, comprising: an annularvalve body having a lumen extending between an upstream end of theannular valve body and a downstream end of the annular valve body; aplurality of atrial anchors extending from the annular valve body, eachatrial anchor having a proximal end secured to the annular valve bodyand a terminal end opposite from the proximal end; and a plurality ofventricular anchors extending from the annular valve body, eachventricular anchor having a proximal end secured to the annular valvebody and a terminal end opposite from the proximal end, wherein theprosthetic heart valve is configured to be arranged in: a deliveryconfiguration in which the annular valve body, atrial anchors, andventricular anchors are configured to be contained at least partiallywithin a delivery device and are arranged in respective deliverypositions, and a deployed-anchor configuration in which the atrialanchors and the ventricular anchors move radially outward from theirrespective delivery positions while the annular valve body remains inits delivery position, at least one atrial anchor includes a pivotingportion configured to extend from the annular valve body in an upstreamdirection when the prosthetic heart valve is in the deliveryconfiguration and to extend from the annular valve body in a downstreamdirection when the prosthetic heart valve is in the deployed-anchorconfiguration, wherein the terminal end of the at least one atrialanchor is configured to be situated radially-outward from the pivotingportion of the at least one atrial anchor, relative to a longitudinalaxis of the annular valve body, when the prosthetic heart valve is inthe deployed-anchor configuration, and a portion of at least oneventricular anchor is configured to abut the annular valve body when theprosthetic heart valve is in the delivery configuration.
 74. Theprosthetic heart valve of claim 73, wherein the at least one atrialanchor and the at least one ventricular anchor are configured to extendfrom the annular valve body in an upstream direction parallel to thelongitudinal axis of the annular valve body when the prosthetic heartvalve is in the delivery configuration.
 75. The prosthetic heart valveof claim 73, wherein the terminal end of the at least one ventricularanchor is configured to be flush with the annular valve body when theprosthetic heart valve is in the delivery configuration.
 76. Theprosthetic heart valve of claim 73, wherein the at least one atrialanchor includes a single point of connection to the annular valve body.77. The prosthetic heart valve of claim 73, wherein the prosthetic heartvalve is additionally configured to be arranged in a fully-expandedconfiguration, the annular valve body having a larger diameter when theprosthetic heart valve is in the fully-expanded configuration than whenthe prosthetic heart valve is in the delivery and deployed-anchorconfigurations.
 78. The prosthetic heart valve of claim 77, the pivotingportion of the at least one atrial anchor is configured to extend fromthe annular valve body in a downstream direction when the prostheticheart valve is in the fully-expanded configuration.
 79. The prostheticheart valve of claim 78, wherein the terminal end of the at least oneatrial anchor is configured to be situated radially-outward from thepivoting portion of the at least one atrial anchor, relative to thelongitudinal axis of the annular valve body, when the prosthetic heartvalve is in the fully-expanded configuration.
 80. The prosthetic heartvalve of claim 73, wherein the at least one atrial anchor includes anupstanding portion configured to extend in an upstream direction whenthe prosthetic heart valve is in the deployed-anchor configuration, theupstanding portion including the terminal end of the at least one atrialanchor.
 81. The prosthetic heart valve of claim 73, wherein the annularvalve body comprises: an annular outer frame; and an inner framepositioned at least partially within the annular outer frame, whereinthe plurality of ventricular anchors extend from the annular outer frameand the plurality of atrial anchors extend from the inner frame.
 82. Theprosthetic heart valve of claim 81, wherein the portion of the at leastone ventricular anchor is configured to abut a portion of the innerframe when the prosthetic heart valve is in the delivery configuration.83. A prosthetic heart valve, comprising: an annular valve body having alumen extending between an upstream end of the annular valve body and adownstream end of the annular valve body; a plurality of atrial anchorsextending from the annular valve body, each atrial anchor having aproximal end secured to the annular valve body and a terminal endopposite from the proximal end; and a plurality of ventricular anchorsextending from the annular valve body, each ventricular anchor having aproximal end secured to the annular valve body and a terminal endopposite from the proximal end, wherein the prosthetic heart valve isconfigured to be arranged in: a delivery configuration in which theatrial anchors and ventricular anchors are configured to be contained atleast partially within a delivery device and are arranged in respectivedelivery positions, and a deployed-anchor configuration in which theatrial anchors and the ventricular anchors move radially outward fromtheir respective delivery positions, at least one atrial anchor includesa pivoting portion configured to extend from the annular valve body inan upstream direction when the prosthetic heart valve is in the deliveryconfiguration and to extend from the annular valve body in a downstreamdirection when the prosthetic heart valve is in the deployed-anchorconfiguration, and a first portion of at least one ventricular anchor isconfigured to abut the annular valve body when the prosthetic heartvalve is in the delivery configuration and a second portion of the atleast one ventricular anchor is configured to be situated upstream fromat least part of the pivoting portion of the at least one atrial anchorwhen the prosthetic heart valve is in the deployed-anchor configuration.84. The prosthetic heart valve of claim 83, wherein the at least oneatrial anchor and the at least one ventricular anchor are configured toextend from the annular valve body in an upstream direction parallel toa longitudinal axis of the annular valve body when the prosthetic heartvalve is in the delivery configuration.
 85. The prosthetic heart valveof claim 83, wherein the first portion of the at least one ventricularanchor is arranged between the second portion and the proximal end ofthe at least one ventricular anchor.
 86. The prosthetic heart valve ofclaim 83, wherein the terminal end of the at least one atrial anchor isconfigured to be situated at a position upstream and radially-outwardfrom the pivoting portion of the at least one atrial anchor, relative toa longitudinal axis of the annular valve body, when the prosthetic heartvalve is in the deployed-anchor configuration.
 87. The prosthetic heartvalve of claim 83, wherein the prosthetic heart valve is additionallyconfigured to be arranged in a fully-expanded configuration, the annularvalve body having a larger diameter when the prosthetic heart valve isin the fully-expanded configuration than when the prosthetic heart valveis in the delivery and deployed-anchor configurations.
 88. Theprosthetic heart valve of claim 87, wherein the diameter of the annularvalve body remains constant when the prosthetic heart valve transitionsfrom the delivery configuration to the deployed-anchor configuration.89. The prosthetic heart valve of claim 87, wherein the pivoting portionof the at least one atrial anchor is configured to extend from theannular valve body in a downstream direction when the prosthetic heartvalve is in the fully-expanded configuration, and the terminal end ofthe at least one atrial anchor is configured to be situatedradially-outward from the pivoting portion of the at least one atrialanchor, relative to a longitudinal axis of the annular valve body, whenthe prosthetic heart valve is in the fully-expanded configuration. 90.The prosthetic heart valve of claim 83, wherein the at least one atrialanchor includes an upstanding portion configured to extend in anupstream direction when the prosthetic heart valve is in thedeployed-anchor configuration, the upstanding portion including theterminal end of the at least one atrial anchor.
 91. The prosthetic heartvalve of claim 83, wherein the annular valve body comprises: an annularouter frame; and an inner frame positioned at least partially within theannular outer frame, wherein the plurality of ventricular anchors extendfrom the annular outer frame and the plurality of atrial anchors extendfrom the inner frame.
 92. The prosthetic heart valve of claim 91,wherein the portion of the at least one ventricular anchor is configuredto abut a portion of the inner frame when the prosthetic heart valve isin the delivery configuration.